NCT04555369

Brief Summary

The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 19, 2021

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

September 15, 2020

Last Update Submit

July 13, 2021

Conditions

Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

  • Response rate

    the response rate predicted by ct-DNA

    2 months

Secondary Outcomes (2)

  • Progression free survival

    2 months

  • Overall survival

    2 months

Study Arms (1)

ct-DNA

EXPERIMENTAL

The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.

Genetic: ct-DNA

Interventions

ct-DNAGENETIC

The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.

Also known as: circulating tumor DNA
ct-DNA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function

You may not qualify if:

  • patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Circulating Tumor DNA

Intervention Hierarchy (Ancestors)

Cell-Free Nucleic AcidsNucleic AcidsNucleic Acids, Nucleotides, and NucleosidesDNA, NeoplasmDNA

Central Study Contacts

Weijian Guo, phD

CONTACT

8621-64175590iamchangjinjia@163.com

Weijian Guo

CONTACT

8621-64175590iamchangjinjia@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD, Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 18, 2020

Study Start

September 23, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2025

Last Updated

July 19, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)