The Value of ctDNA on Chemotherapy Efficacy for mCRC | NCT04555369

Studies
The Value of ctDNA on Chemotherapy Efficacy for mCRC

NCT04555369

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Jul 19, 2021Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Circulating Tumor DNA

Interventions

ct-DNA

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2020Actual

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Sep 15, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2021

Last Update Posted Date

Jul 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weijian Guo, MD,PhD, Fudan University Shanghai Cancer Center, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ct-DNA	Genetic	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	the response rate predicted by ct-DNA	2 months

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival		2 months
Overall survival		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weijian Guo, phD	Contact	8621-64175590		iamchangjinjia@163.com
Weijian Guo	Contact	8621-64175590		iamchangjinjia@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074141	Circulating Tumor DNA

Ancestor Terms

ID	Term
D000073888	Cell-Free Nucleic Acids
D009696	Nucleic Acids
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004273	DNA, Neoplasm

Browse Leaves

Not provided

Browse Branches

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