Clinical trial NCT03256084: Tumoral Circulating Cells and Colorectal Cancer Progression
Official title: Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Beckman Coulter, Inc.
First posted: 2017-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of CTC features
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Luc RAOUL, Pr
role: STUDY_DIRECTOR
References:
citation: Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Vieitez JM, Alonso V, Gravalos C, Escudero P, Vera R, Aranda E, Garcia-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, Lopez-Ladron A, Diaz-Rubio E. Role of circulating tumor cells as prognostic marker in resected stage III colorectal cancer. Ann Oncol. 2015 Mar;26(3):535-41. doi: 10.1093/annonc/mdu568. Epub 2014 Dec 15.
citation: Hodgkinson CL, Morrow CJ, Li Y, Metcalf RL, Rothwell DG, Trapani F, Polanski R, Burt DJ, Simpson KL, Morris K, Pepper SD, Nonaka D, Greystoke A, Kelly P, Bola B, Krebs MG, Antonello J, Ayub M, Faulkner S, Priest L, Carter L, Tate C, Miller CJ, Blackhall F, Brady G, Dive C. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer. Nat Med. 2014 Aug;20(8):897-903. doi: 10.1038/nm.3600. Epub 2014 Jun 1.
citation: Yu M, Bardia A, Aceto N, Bersani F, Madden MW, Donaldson MC, Desai R, Zhu H, Comaills V, Zheng Z, Wittner BS, Stojanov P, Brachtel E, Sgroi D, Kapur R, Shioda T, Ting DT, Ramaswamy S, Getz G, Iafrate AJ, Benes C, Toner M, Maheswaran S, Haber DA. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014 Jul 11;345(6193):216-20. doi: 10.1126/science.1253533.
citation: Khoo BL, Lee SC, Kumar P, Tan TZ, Warkiani ME, Ow SG, Nandi S, Lim CT, Thiery JP. Short-term expansion of breast circulating cancer cells predicts response to anti-cancer therapy. Oncotarget. 2015 Jun 20;6(17):15578-93. doi: 10.18632/oncotarget.3903.