Value of ctDNA in the Treatment of Multiple Primary Cancers

December 7, 2021 updated by: Zhiguo Luo, MD, PhD, Fudan University

Exploratory Study on Gene Profiling of Circulating Tumor DNA（ctDNA） of Multiple Primary Cancers （MPC） and Its Value in Guidance of Clinical Choice of Drugs

This trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood circulating tumor DNA (CT-DNA) gene profile of patients with multiple primary tumors (MPC) and to evaluate the exploratory study for guiding drug selection. Patients with multiple primary tumors who met the inclusion criteria and did not meet the exclusion criteria will be enrolled in this study. CtDNA test will be used for CT-DNA gene profile study, and whether the test results can guide drug selection will be evaluated.The expected enrollment time is 12 months, and clinical observation is performed until disease progression and patient death.Additional CT-DNA tests will be performed as the disease progresses (2 cT-DNA tests in total).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood CT-DNA gene profile of patients with multiple primary tumors and to evaluate the exploratory study for guiding drug selection. Patients with multiple primary tumors who met the inclusion criteria and did not meet the exclusion criteria will be enrolled in this study. CtDNA test will be used for CT-DNA gene profile study, and whether the test results can guide drug selection will be evaluated.The expected enrollment time is 12 months, and clinical observation is performed until disease progression and patient death. Additional CT-DNA tests will be performed as the disease progresses (2 cT-DNA tests in total).

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.
Interventional

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.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cencer Center

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

Description

Inclusion Criteria:

  • Patients who were assessed to meet the diagnostic criteria for multiple primary tumors : each tumor had to be invasive histologically
  • Each tumor has its own pathologic appearance
  • Each tumor occurs in a different organ and must exclude metastasis or recurrence
  • progress or failure after treatment on a standard regimen for related primary cancer
  • regardless of gender, between 18 and 75
  • The Eastern Cancer Collaboration Group (ECOG) scored 0 ~ 1 in physical condition (PS)
  • has an estimated survival of more than three months;
  • During 7 days (including 7 days) before screening, the laboratory test data were obtained: neutrophil count ≥1.5×109/L, platelet count ≥90×109/L, hemoglobin ≥90g/L (no transfusion within 14 days), serum total bilirubin ≤1.25 times normal upper limit (ULN);alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 x ULN (≤5x ULN in patients with liver metastasis);Serum creatinine ≤1.25 x ULN and creatinine clearance ≥60ml/min;
  • Participating subjects (or their legal representative/guardian) had to sign an informed consent form saying they understood the study's objectives, understood the required procedures, and were willing to participate in the study.

Exclusion Criteria:

  • have standard treatment for metastatic disease;
  • Participants were given any experimental or antineoplastic drugs during the first four weeks of enrollment;
  • Either symptomatic brain or meningeal metastasis (unless the patient is treated for something)At 6 months, imaging results were negative within 4 weeks prior to study entry and tumor-related clinical symptoms were stable at study entry);
  • clinically active bleeding;
  • Women who are pregnant or breastfeeding;Those who are fertile but do not take adequate contraceptive measures;
  • addicted to alcohol or drugs;
  • either major organ failure or other serious illness, including interstitial pneumonia, clinically relevant coronary disease, cardiovascular disease, or having myocardial infarction, congestive heart failure, unstable angina, pronounced pericardial effusion, or unstable arrhythmia in the first 6 months of the study;
  • A history of severe neurological or mental illness;Severe infection;Active disseminated intravascular coagulation or other comorbidities that, in the investigator's judgment, seriously compromised the patient's safety or prevented the patient from completing the study.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ct-DNA test in MPC
treatment according to ct-DNA results:For Patients with abnormal gene changes of corresponding targeted drugs are recommended to use corresponding targeted therapy or immunotherapy drugs;For Patients without abnormal gene changes of corresponding targeted drugs, Treatment of Physician's Choice (TPC) is recommended.
Genetic: ct-DNA guided therapy
treatment according to ct-DNA results:For Patients with abnormal gene changes of corresponding targeted drugs are recommended to use corresponding targeted therapy or immunotherapy drugs;For Patients without abnormal gene changes of corresponding targeted drugs, Treatment of Physician's Choice (TPC) is recommended.
Other Names:
  • treatment according to ct-DNA results

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
Time Frame
number of patients with aberrant CT-DNA gene profile
Time Frame: 8 months
8 months

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
Time Frame
number of patients with drugable CT-DNA gene profile
Time Frame: 2 months
2 months

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.
Fudan University

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.
December 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.
September 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.
September 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).
September 7, 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.
December 7, 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.
December 20, 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.
December 20, 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.
December 7, 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.
September 1, 2021

More Information

Terms related to this study

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.
  • Fudan CMP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings