Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
Coca-Colon
1 other identifier
interventional
200
1 country
4
Brief Summary
The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
4 active sites
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 29, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 17, 2016
August 1, 2016
5.8 years
September 29, 2010
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prediction of tumor progression
sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)
3 months
Secondary Outcomes (1)
Prediction of tumor response
3 months
Study Arms (1)
Tumor markers
OTHERmeasurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA )
Interventions
blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA
Eligibility Criteria
You may qualify if:
- Patient has Stage IV colorectal adenocarcinoma histologically proved
- Patient has at least one measurable lesion
- Patient has performance status 0-2 on the WHO performance scale
- Patient is male or female, and \> 18 years of age
- Patient has agree to participate by giving written informed consent
You may not qualify if:
- Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre François Baclesse
Caen, 14000, France
University Hospital
Caen, 14000, France
Centre Frédéric Joliot
Rouen, 76000, France
University Hospital
Rouen, 76000, France
Related Publications (1)
Sefrioui D, Beaussire L, Gillibert A, Blanchard F, Toure E, Bazille C, Perdrix A, Ziegler F, Gangloff A, Hassine M, Elie C, Bignon AL, Parzy A, Gomez P, Thill C, Clatot F, Sabourin JC, Frebourg T, Benichou J, Bouhier-Leporrier K, Gallais MP, Sarafan-Vasseur N, Michel P, Di Fiore F. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC). Br J Cancer. 2021 Aug;125(5):725-733. doi: 10.1038/s41416-021-01431-9. Epub 2021 Jun 10.
PMID: 34112948DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre MICHEL, Pr
UH Rouen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2010
First Posted
September 30, 2010
Study Start
October 1, 2010
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
August 17, 2016
Record last verified: 2016-08