Circulating-free DNA Assessment as a Tool to Predict Colorectal Cancer in Subjects With a Positive Fecal Immunoassay.

NCT03981679 | Completed

• 1 other identifier: PROICM 2017-02 DEP
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC): is one of the most frequent cancers, with almost 42152 new cases estimated in France for 2012. There are 3 levels of risk of developing CRC: moderate, high or very high. At each level of risk, appropriate follow-up recommendations are made. Immunological tests for fecal occult blood tests have emerged in recent years and have rapidly become established as benchmark tests in Europe and then in France (OC Sensor test) as part of mass screening. In the case of a positive immunological test, a diagnostic colonoscopy must be systematically organized in order to characterize the possible recto-colic cause of the digestive bleeding thus observed. Measurement of the DNA present in the circulating blood (circulating DNA or cfDNA): allowed a significant advance in the personalized management of cancers, as a non-invasive test capable of producing diagnostic, prognostic, theranostic, and of therapeutic follow-up type. The aim of the work is to measure the cfDNA concentration in subjects undergoing colonoscopy because of a positive immunological fecal test.

Conditions

Colorectal Cancer

Keywords

colonoscopy; CRC screening; cfDNA; Intplex; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• AUC

  Area under the ROC curve (AUC) of the total cfDNA concentration.

  Until the study completion of 2 years

Secondary Outcomes (2)

• cfDNA threshold

  Until the study completion of 2 years

• Intplex parameters

  Until the study completion of 2 years

Study Arms (1)

Biological collection

EXPERIMENTAL

For all the patients include in the study : \- Blood samples collected before the colonoscopy In parallel to this biological collection, standardized clinical data will be entered into a database

Other: Biological collection

Interventions

Biological collection OTHER

The biological collection will also include samples of blood samples collected before colonoscopy

Biological collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ at 18 years old,
• Patient with a positive immunological screening test,
• Patient requiring a colonoscopy
• Patient having given his informed, written and express consent.

You may not qualify if:

• Patient not affiliated to a social security scheme,
• Subject under tutelage, curatorship or safeguard of justice,
• Patient in an emergency situation,
• Acute or chronic inflammatory disease,
• Patient having made an intense effort 3 days before sampling.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

ICM - Institut régional du Cancer Montpellier

Montpellier, Occ, 34298, France

Location

Related Publications (5)

• Segnan N, Armaroli P, Bonelli L, Risio M, Sciallero S, Zappa M, Andreoni B, Arrigoni A, Bisanti L, Casella C, Crosta C, Falcini F, Ferrero F, Giacomin A, Giuliani O, Santarelli A, Visioli CB, Zanetti R, Atkin WS, Senore C; SCORE Working Group. Once-only sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian Randomized Controlled Trial--SCORE. J Natl Cancer Inst. 2011 Sep 7;103(17):1310-22. doi: 10.1093/jnci/djr284. Epub 2011 Aug 18.

  PMID: 21852264 RESULT

• Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

  PMID: 22612596 RESULT

• Minozzi S, Armaroli P, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Principles of evidence assessment and methods for reaching recommendations. Endoscopy. 2012 Sep;44 Suppl 3:SE9-14. doi: 10.1055/s-0032-1309781. Epub 2012 Sep 25.

  PMID: 23012125 RESULT

• US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.

  PMID: 27304597 RESULT

• Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

  PMID: 24698732 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• ADENIS Antoine, MD

  Institut régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: June 5, 2018
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)