Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention

NCT05635630 | Unknown

• 1 other identifier: ctDNA-nedCRC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are:

1. 1.Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring?
2. 2.Whether the patients with ctDNA positive status could benefit from early therapeutic intervention.

Conditions

Metastatic Colorectal Cancer; No Evidence of Disease Status; ctDNA Monitoring

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS) time

  To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies.

  From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

Secondary Outcomes (4)

• Overall survival (OS) time

  From the date of surgery until the date of death from any cause, assessed up to 2 years.

• The positive rate of ctDNA in mCRC patients with NED status.

  Post-operation 1 month

• The concordance index of ctDNA defined NED and radiology defined NED status.

  When the clinic trail is finished, up to 2 years.

• The rate of achieving NED status when relapses happen.

  When the relapses happen, up to 2 years.

Study Arms (2)

ctDNA positive

EXPERIMENTAL

Other: ctDNA and adjuvant therapy

ctDNA negative

EXPERIMENTAL

Other: ctDNA

Interventions

ctDNA and adjuvant therapy OTHER

Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months.

ctDNA positive

ctDNA OTHER

Patients of ctDNA negative group are monitored by ctDNA every 3 months.

ctDNA negative

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old. Both male and female are eligible.
• Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology.
• With potential opportunity of achieving NED status (including liver metastasis, lung metastasis, solitary lymph node metastasis, ovarian metastasis or focal pelvic metastasis), regardless of neo-adjuvant therapy or transforming therapy.
• Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy)
• Eastern Cooperative Oncology Group (ECOG) grade 1-2.
• Approve the informed consent.
• Available for tumor sample obtained by resection or aspiration.
• Available for peripheral blood collection (10mL per tube for 2 tubes)

You may not qualify if:

• Cannot get histologic or cytologic diagnosis.
• Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition.
• Accompany with widespread metastasis and cannot achieve NED status by focal therapy, such as bone metastasis, peritoneum metastasis, diffuse liver or lung metastasis or malignant effusion, etc.
• Inadequate bone marrow reserve and organ function.
• Uncontrolled or severe systemic diseases, such as uncontrolled hyperplasia, severe infection, hepatitic B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, etc.
• History of alcohol or drug abuse.
• Pregnant or lactating women.
• Cannot get tumor sample.

Sponsors & Collaborators

• Fudan University: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Circulating Tumor DNA

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

Intervention Hierarchy (Ancestors)

Cell-Free Nucleic Acids; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; DNA, Neoplasm; DNA

Central Study Contacts

Junjie Peng

CONTACT

+86-021-64175590; pengjj67@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 2, 2022
• Study Start: June 24, 2022
• Primary Completion: December 24, 2023
• Study Completion: December 24, 2025
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

CN (1)