Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis

March 19, 2021 updated by: Shanghai Minimally Invasive Surgery Center

a Multi-omics Cohort Study of Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis

This is a two stage nested case-control study to construct the hologram plane , explore biomarkers and screening original drugs of metastatic colorectal cancer.

Study Overview

Status

Status

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

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.

Detailed Description

Stage Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 200 colorectal cancer cases( at least 160 stage Ⅲ cases,40 stage Ⅳ（synchronous metastasis）).Stage Ⅱ is a nested case-control study. 200 eligible cases enrolled in phaseⅠwill be followed up for 5 years to record recurrence, metastasis and to collect biospecimen . Each case with the study outcome will be matched with the corresponding control according to the proportion of 1:1 according to age, sex and other conditions, and further analysis will be made.

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 (Anticipated)

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.
200

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.

Study Locations

  • China
    • Sahgnhai
      • Shanghai, Sahgnhai, China, 200000
        • Recruiting
        • Shanghai Ruijin Hospttal
        • Contact:

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with CRC (Stage III and Stage IV)

Description

Inclusion Criteria:

  • Baseline population (stage III colorectal cancer) inclusion criteria:

    1. Aged 18-75.
    2. Physical condition (ECOG) score ≤ 1.
    3. Colorectal adenocarcinoma was confirmed by histopathology.
    4. No family history of hereditary tumor.
    5. Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
    6. Preoperative clinical stage is stage III.
    7. Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
    8. Enough primary surgical or biopsy tissues for examination.
    9. Enough peripheral blood samples for examination.
    10. Agree to sign informed consent to participate in this project.

Baseline population (stage Ⅳ colorectal cancer) inclusion criteria:

  1. Aged 18-75.
  2. Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
  3. Not yet received antineoplastic therapy.
  4. Baseline imaging evaluation shows at least one measurable focus.
  5. Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination.
  6. Enough peripheral blood samples for examination.
  7. Expected survival time ≥ 3 months.
  8. Provide information such as demography, current medical history or current tumor disease, pathological diagnosis and staging of tumor, physical status of ECOG, radiographic evaluation of tumor, etc.
  9. Agree to sign informed consent to participate in this project.

Metastasis colorectal cancer cohort study inclusion criteria:

  1. Aged 18-75.
  2. Physical condition (ECOG) score ≤ 1.
  3. Colorectal adenocarcinoma was confirmed by histopathology.
  4. No family history of hereditary tumor.
  5. Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
  6. Preoperative clinical stage is stage III and the postoperative pathological stage was confirmed as stage III.
  7. Agreed to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
  8. Enough primary surgical or biopsy tissues for examination.
  9. Enough peripheral blood samples for examination.
  10. Agree to sign informed consent to participate in this project.

Exclusion Criteria:

  • Baseline population (stage III colorectal cancer) exclusion criteria:

    1. Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
    2. Postoperative pathological stage was confirmed as stage II.
    3. Abnormal function of heart, lung, liver, kidney, hematopoiesis or bone marrow reserve, which cannot tolerate operation or chemotherapy.
    4. Diagnosed with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
    5. Having mental illness or other serious cardiovascular diseases.
    6. Pregnancy or lactation or planned pregnancy within one year.
    7. Emergency operation (perforation, bleeding, intestinal obstruction, etc.).

Baseline population (stage Ⅳcolorectal cancer) exclusion criteria:

  1. Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
  2. Nervous system metastasis.
  3. Complicated with other malignant tumors.
  4. Having poorly controlled chronic concomitant diseases that affect the prognosis.
  5. Any complication that may affect the results of the study .

Metastasis colorectal cancer cohort study exclusion criteria:

  1. Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
  2. Abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which cannot tolerate operation and chemotherapy.
  3. Diagnoses with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
  4. Having mental illness or other serious cardiovascular disease.
  5. Pregnancy or lactation or planned pregnancy within one year.
  6. Emergency operation (perforation, bleeding, intestinal obstruction, etc.).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
recurrence or metastasis provened by imageologic diagnosis (PFS)
Time Frame: May 31, 2023
tumor metastasis or progression occurred during the enrolment period
May 31, 2023

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.
Shanghai Minimally Invasive Surgery Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RenJi Hospital
Shanghai Jiao Tong University School of Medicine
Science and Technology Commission of Shanghai Municipality

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: Sun Jing, PhD, Shanghai Jiao Tong University School of Medicine

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 (Anticipated)

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.
June 1, 2021

Primary Completion (Anticipated)

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.
May 1, 2022

Study Completion (Anticipated)

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 1, 2023

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 12, 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.
January 15, 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.
January 19, 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.
March 23, 2021

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.
March 19, 2021

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.
March 1, 2021

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.
  • Metastatic CRC cell fate

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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