Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment (CONTEST)

May 27, 2024 updated by: University of Aarhus
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Anne-Mette Hvas, MD, PhD
  • Phone Number: +4523348252
  • Email: annehvas@rm.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8000
        • Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will include patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC and rectal cancer patients undergoing minimally invasive rectal cancer resection. Patients will be identified at the outpatient clinic and undergo surgical treatment at the Department of Surgery, Aarhus University Hospital, Denmark.

Description

Inclusion Criteria:

Cytoreductive surgery with HIPEC patients:

  • Able to give informed consent
  • Age ≥ 18 years
  • Diagnosed with peritoneal metastases from colorectal cancer
  • Planned to undergo cytoreductive surgery with HIPEC

Minimally invasive rectal cancer patients:

  • Able to give informed consent
  • Age ≥ 18 years
  • Diagnosed with rectal cancer
  • Planned to undergo minimal invasive rectal cancer resection with one of: total mesorectal excision, partial mesorectal excision or abdominoperineal excision

Exclusion Criteria (both groups):

  • Thromboembolic event within 90 days before surgery
  • Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
48 cytoreductive surgery with HIPEC patients
48 patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC (cytoreductive surgery with HIPEC patients)
48 minimally invasive patients
48 rectal cancer patients undergoing minimally invasive rectal cancer resection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The difference between changes in concentration of prothrombin fragment 1+2.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The difference between changes in platelet concentration from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years
The difference between changes in concentration of immature platelets from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years
The difference between changes in concentration of plasma selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years
The difference between changes in activated partial thromboplastin time "APTT" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in international normalized ratio "INR" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasma fibrinogen from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of coagulation factor VIII from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of von wildebrand factor from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of thrombin-antithrombin complex from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in thrombin generation before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.

The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

Thrombin generation will be measured by:

Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).
Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.

The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasminogen activator inhibitor-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of fibrin d-dimer from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in global hemostasis by Rotational thromboelastometry (ROTEM) from before surgery to the end of surgery (both groups)
Time Frame: Data will be analyzed, assessed, and presented within three years.

The difference will be measured in blood samples from before surgery to the end of surgery (both groups).

ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of syndecan-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of sE-selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of soluble thrombomodulin. from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of hemoglobin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of leucocytes from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration C-reactive protein (CRP) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of prothrombin fragment 1+2. from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in platelet concentration from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of immature platelets from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in activated partial thromboplastin time "aPTT" (seconds) from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in activated international normalized ratio "INR" (seconds) from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasma fibrinogen from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of coagulation factor VIII from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of von wildebrand factor from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of thrombin-antithrombin complex from the end of cytoreductive surgery to the end HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in thrombin generation from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Thrombin generation will be measured by: Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).
Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasminogen activator inhibitor-1 from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of fibrin d-dimer from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of global hemostasis measured by Rotational thromboelastometry (ROTEM) from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.

The difference will be measured in blood samples from the end of cytoreductive surgery to the end HIPEC.

ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of syndecan-1 from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of sE-selectin from the end of cytoreductive surgery to the end of HIPEC
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of soluble thrombomodulin from the end of cytoreductive surgery to the end of HIPEC
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of hemoglobin from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of leucocytes from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of C-reactive protein (CRP) from the end of cytoreductive surgery to the end of HIPEC.
Time Frame: Data will be analyzed, assessed, and presented within three years
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Data will be analyzed, assessed, and presented within three years
Incidence of deep vein thrombosis measured by doppler ultrasonography in colorectal cancer patients undergoing minimally invasive rectal cancer resection.
Time Frame: Data will be analyzed, assessed, and presented within three years
Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.
Data will be analyzed, assessed, and presented within three years
Incidence of deep venous thrombosis measured by doppler ultrasonography in colorectal cancer patients undergoing cytoreductive surgery with HIPEC
Time Frame: Data will be analyzed, assessed, and presented within three years
Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.
Data will be analyzed, assessed, and presented within three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne-Mette Hvas, MD, PhD, Thrombosis and Haemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-212-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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