Loading clinical trials...

UNKNOWNNA

ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study

NCT04752930•Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be a man or woman of at 18-75;
•Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；
•Patients with primary colorectal cancer proven by pathology；
•Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);
•6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
•Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)；
•Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ;
•Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study.

Exclusion Criteria

•Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;
•ASA class Ⅳ to Ⅴ;
•Patients who have other existence of distant metastasis outside the abdomen;
•Patients with serious mental illness;
•Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
•Patients who cannot be followed up as scheduled;
•Patients who participated in other clinical studies within 3 months prior to the trial;
•Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

August 24, 2020

Primary Completion Date

September 24, 2023

Completion Date

August 24, 2025

Last Updated

February 12, 2021

Enrollment

138

ESTIMATED participants

Conditions

Colorectal CancerPeritoneal Metastases

Interventions

ctDNA monitoring

DIAGNOSTIC_TEST

Imageology

DIAGNOSTIC_TEST

Contacts

Hui Wang, MD, PhD

CONTACT

13926424886 wang89@mail.sysu.edu.cn

Tenghui Ma, MD, PhD

CONTACT

13560232462 austin_2004@163.com

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors