Clinical trial NCT01212510: Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
Official title: Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer
circulating tumor markers
circulating tumor cell
circulating tumor DNA
marker's kinetic
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Prospective cohort study of patients treated with systemic chemotherapy for unresectable metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer has been published (J Clin Oncol 2008;26:3681-6). The present study is designed to validate the previous data. The secondary purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy. Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy and biotherapy validate in this clinical situation by the French National Cancer Institute (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC will be performed at day 1 and 42 of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Primary outcomes:
measure: Prediction of tumor progression
timeFrame: 3 months
Secondary outcomes:
measure: Prediction of tumor response
timeFrame: 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: University Hospital
city: Rouen
country: France
facility: Centre Frédéric Joliot
city: Rouen
country: France
facility: University Hospital
Study officials:
affiliation: UH Rouen
name: Pierre MICHEL, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.