Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis

NCT ID: NCT04714814

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Stage III Colorectal Cancer Stage IV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


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.


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

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.).


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 .


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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Municipal Science and Technology Commission

OTHER_GOV

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sun Jing, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sun Jing, PhD

Role: CONTACT

13524284622

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yanye Yang, Bachelor

Role: primary

+86-13636419858

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Metastatic CRC cell fate

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.