Phenotyping of Small Bowel Adenocarcinoma

NCT02976090 | Completed

• 1 other identifier: NI14026
• Study Type: observational
• Target: 187
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite the fact that small intestine makes up 75% of the length of the digestive tract and 90% of its mucosal surface area, small bowel adenocarcinoma (SBA) is rare. SBA is not equally dispatched along the small bowel, a predisposing disease is frequently associated. All these data suggest particular carcinogenesis pathway. SBA carries poor prognosis at all stages and no standard treatment have proved efficacy. So far, no data are available for targeted therapy. From the literature and a previous study of our group some biologic data showed that SBA carcinogenesis is closer to colorectal than gastric carcinogenesis. Nevertheless, some differences arise (ie: low Adenomatous Polyposis Coli mutation rate or frequent DNA mismatch repair deficiency). Even if some trends are founded the prognostic value of molecular alteration and phenotype variation according to small bowel segment, or predisposing disease could not been demonstrate due to small sample size. BIONADEGE study is a planned biologic ancillary study of the NADEGE cohort that enrolled 366 patients with SBA from 2009 to 2012 in France. The tumour blocks and clinical data of 187 patients have been collected. The main objective is to assess the prognostic value for recurrence free survival (RFS) in non-metastatic patients and overall survival (OS) in metastatic patients of molecular alteration in a set of 46 genes and abnormal protein expression potentially implicated in carcinogenesis. The mains secondary objectives are: 1) to identify potential mutation targetable in small intestine tumours and protein expression, 2) to state the frequency of molecular alteration according to the tumour location, stage or predisposing disease and established clinico-biologic correlation. Tissue microarrays will be performed and several potential prognostic markers will be assessed. Sequencing on tumour DNA will investigate the presence of 740 hot spot somatic mutations in 46 genes involved.The abnormal protein expression or the genetic alterations with an expected frequency superior to 10% will be assessed as potential prognostic factor to RFS and OS. These evaluations on a large cohort could allow comparison between pathways and will offer better knowledge of tumour molecular phenotype and prognosis will give rational for targeted therapy trials The predisposing diseases for SBA involved several different carcinogenesis pathways. Finally, a molecular classification of SBA will be attempt.

Conditions

Small Bowel Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• RFS in non-metastatic patients according to 46 genes and abnormal protein expression potentially implicated in carcinogenesis.

  3 years

Secondary Outcomes (2)

• OS in metastatic patients according to 46 genes and abnormal protein expression potentially implicated in carcinogenesis

  3 years

• Rate of MMR status

  3 years

Eligibility Criteria

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

Study Population

patients included in NADEGE cohort

You may qualify if:

• patients included in NADEGE cohort
• patients with available and exploitable biological samples from NADEGE cohort

You may not qualify if:

• none

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University of Paris 5 - Rene Descartes: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• GERCOR - Multidisciplinary Oncology Cooperative Group: collaborator

Related Publications (1)

• Aparicio T, Svrcek M, Henriques J, Afchain P, Lievre A, Tougeron D, Gagniere J, Terrebonne E, Piessen G, Legoux JL, Lecaille C, Pocard M, Gornet JM, Zaanan A, Lavau-Denes S, Lecomte T, Deutsch D, Vernerey D, Puig PL. Panel gene profiling of small bowel adenocarcinoma: Results from the NADEGE prospective cohort. Int J Cancer. 2021 Apr 1;148(7):1731-1742. doi: 10.1002/ijc.33392. Epub 2021 Jan 4.

  PMID: 33186471 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumour block

Study Officials

• Sabine HELFEN

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 24, 2020
• Last Updated: January 13, 2021

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share