Tumoral Circulating Cells and Colorectal Cancer Progression

Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03256084

Enrollment

120

Registered

2017-08-21

Start date

2017-07-17

Completion date

2025-05-31

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

Detailed description

This study aims at allowing a better understanding of which circulating tumor cells (CTC) have the higher risk of metastasis of in the overall population of CTC. Prospective monocenter open-label study. In the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage II/III, metastatic non resectable, metastatic potentially resectable). Tissue samples will be collected for patients scheduled for surgery.

Interventions

PROCEDUREBlood and tumor samples

Blood and tumor samples

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient of more than 18 years old 2. Histological diagnosis of colic adenocarcinoma metastatic or not 3. Before any treatment with systemic chemotherapy 4. Patient affiliated to, or beneficiating of the national security 5. Patient having signed informed consent

Exclusion criteria

1. Patient with previous chemothrapy treatment 2. Patient with more than one evolutive tumoral pathology 3. Patient under long-term immunosuppressor treatment 4. Patient with severe infection 5. Pregnant or breasting woman 6. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of CTC features	Group 1: at surgery, 4 (+/- 1) weeks post-surgery, at progression. Group 2: before chemotherapy, after 4 months treatment (responders), at progression. Group 3: before neoadjuvant surgery, at surgery, 4 (+/- 1) weeks post-surgery, at progression.	Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.

Countries

France

Contacts

Primary ContactDominique GENRE, MD

drci.up@ipc.unicancer.fr+33 4 91 22 37 78

Backup ContactIsabelle BOQUET, PhD