Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis

NCT04714814 | Unknown

• 1 other identifier: Metastatic CRC cell fate
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer Stage III; Colorectal Cancer Stage IV

Keywords

Colorectal , Metastatisis ,Cancer Cell Fate Regulatory Mechanism

Outcome Measures

Primary Outcomes (1)

• recurrence or metastasis provened by imageologic diagnosis (PFS)

  tumor metastasis or progression occurred during the enrolment period

  May 31, 2023

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with CRC (Stage III and Stage IV)

You may qualify if:

• Aged 18-75.
• Physical condition (ECOG) score ≤ 1.
• Colorectal adenocarcinoma was confirmed by histopathology.
• No family history of hereditary tumor.
• Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
• Preoperative clinical stage is stage III.
• Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
• Enough primary surgical or biopsy tissues for examination.
• Enough peripheral blood samples for examination.
• Agree to sign informed consent to participate in this project.
• Aged 18-75.
• Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
• Not yet received antineoplastic therapy.
• Baseline imaging evaluation shows at least one measurable focus.
• Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination.

You may not qualify if:

• Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
• Postoperative pathological stage was confirmed as stage II.
• Abnormal function of heart, lung, liver, kidney, hematopoiesis or bone marrow reserve, which cannot tolerate operation or chemotherapy.
• 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.
• Having mental illness or other serious cardiovascular diseases.
• Pregnancy or lactation or planned pregnancy within one year.
• Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
• Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
• Nervous system metastasis.
• Complicated with other malignant tumors.
• Having poorly controlled chronic concomitant diseases that affect the prognosis.
• Any complication that may affect the results of the study .
• Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
• Abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which cannot tolerate operation and chemotherapy.
• 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.

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead
• Shanghai Municipal Science and Technology Commission: collaborator
• RenJi Hospital: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue samples, blood samples, stool, pleural effusion

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sun Jing, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Jing, PhD

CONTACT

13524284622; sj11788@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CN (1)