NCT02872779

Brief Summary

The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient. The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 18, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

August 16, 2016

Last Update Submit

April 13, 2026

Conditions

Circulating MarkersMetastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Difference from baseline in the number of free mutant DNA in blood

    Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)

    5 weeks

Secondary Outcomes (2)

  • Difference from baseline in the number of free mutant DNA in blood

    3 weeks

  • Evaluation of response based on the RECIST 1.1 guideline

    3 Months

Study Arms (1)

Patients Treated for Metastatic Colorectal cancer

EXPERIMENTAL

Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer

Procedure: Blood sampling for free mutant DNA analysis

Interventions

Blood sampling for free mutant DNA analysisPROCEDURE

Blood sampling for Patients Treated for Metastatic Colorectal cancer

Patients Treated for Metastatic Colorectal cancer

Eligibility Criteria

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

You may qualify if:

  • Male or female, age superior to 18 years.
  • Histologically confirmed metastatic colorectal adenocarcinoma.
  • Measurable disease according to the RECIST 1.1 guideline
  • ECOG performance status \<3.
  • Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days
  • No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy
  • Signed and dated informed consent document.

You may not qualify if:

  • Medical history of cancer within 5 years
  • Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab)
  • Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

  • Grancher A, Beaussire-Trouvay L, Vernon V, Dutherage M, Blondin V, Elie C, Bouhier-Leporrier K, Galais MP, Clabaut T, Bignon AL, Parzy A, Gangloff A, Schwarz L, Leveque E, Sabourin JC, Michel P, Vasseur N, Sefrioui D, Gilibert A, Di Fiore F. ctDNA variations according to treatment intensity in first-line metastatic colorectal cancer. Br J Cancer. 2025 May;132(9):814-821. doi: 10.1038/s41416-025-02971-0. Epub 2025 Mar 15.

    PMID: 40089635RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alice GANGLOFF, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

July 18, 2016

Primary Completion

August 10, 2020

Study Completion

August 10, 2020

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(1)