Tumoral Circulating Cells and Colorectal Cancer Progression
Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers
1 other identifier
interventional
120
1 country
1
Brief Summary
Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Jul 2017
Longer than P75 for not_applicable colorectal-cancer
1 active site
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
June 19, 2017
CompletedStudy Start
First participant enrolled
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedMay 6, 2021
May 1, 2021
4.8 years
June 19, 2017
May 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of CTC features
Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.
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.
Study Arms (1)
Colorectal Cancer
EXPERIMENTALLocalized stage II/III (group 1), metastatic non resectable (group 2), metastatic potentially resectable (group 3). Additional blood samples specific for the research will be collected. Tissue samples will be taken on surgical specimens from surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Patient of more than 18 years old
- Histological diagnosis of colic adenocarcinoma metastatic or not
- Before any treatment with systemic chemotherapy
- Patient affiliated to, or beneficiating of the national security
- Patient having signed informed consent
You may not qualify if:
- Patient with previous chemothrapy treatment
- Patient with more than one evolutive tumoral pathology
- Patient under long-term immunosuppressor treatment
- Patient with severe infection
- Pregnant or breasting woman
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Paoli-Calmetteslead
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Beckman Coulter, Inc.collaborator
Study Sites (1)
Institut Paoli Calmettes
Marseille, 13009, France
Related Publications (4)
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.
PMID: 25515656RESULTHodgkinson 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.
PMID: 24880617RESULTYu 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.
PMID: 25013076RESULTKhoo 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.
PMID: 26008969RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Luc RAOUL, Pr
Institut Paoli-Calmettes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
August 21, 2017
Study Start
July 17, 2017
Primary Completion
May 1, 2022
Study Completion
May 1, 2025
Last Updated
May 6, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share