Biopsy Technique for Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer

NCT03950908 | Completed

• 1 other identifier: FGCS protocol v.10
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Germline mutation in e-cadherin gene (CDH1) is found in approximately 25% to 30% of individuals fulfilling the clinical criteria for hereditary diffuse gastric cancer (HDGC). Prophylactic gastrectomy is the mainstay of the management of cases with pathogenetic CDH1 mutation. However, some individuals refuse gastrectomy and prefer to delay it for medical or psychosocial reasons. For these patients as well as for those in which a pathogenetic mutation is not found, endoscopic surveillance is recommended. The suggested endoscopic protocol involves targeted as well as 30 random biopsies, which is tedious and time-consuming . In order to save time, two specimens can be taken during a single passage of the biopsy forceps ("double-bite" technique). The aim of this study was to determine the adequacy and utility of the "double-bite" technique in patients undergoing surveillance for HDGC as compared to the standard "single-bite technique".

Conditions

Hereditary Diffuse Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of signet ring cell carcinoma (SRCC) foci.

  Evaluating the diagnostic yield of the double-bite technique, by means of identifying SRCC foci, in comparison to the conventional single -bite arm.

  1 year

Secondary Outcomes (4)

• Time to perform biopsy protocol.

  1 year

• Biopsy size

  1 year

• Patients comfort

  1 year

• Dose of sedation.

  1 year

Study Arms (2)

Single bite

OTHER

The single bite technique involved removing the forceps with its specimen after each individual biopsy.

Other: Single bite biopsy technique

Double bite

OTHER

The double-bite technique involved taking an initial biopsy, repositioning the forceps, and taking another biopsy from the same area with the initial specimen still on the forceps.

Other: Double bite biopsy technique

Interventions

Single bite biopsy technique OTHER

During biopsy collection one specimen will be retrieved during a single passage of the biopsy forceps.

Single bite

Double bite biopsy technique OTHER

During biopsy collection two specimens will be retrieved during a single passage of the biopsy forceps.

Double bite

Eligibility Criteria

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

You may qualify if:

• Patients in the Familial Gastric Cancer Registry held in Cambridge fulfilling clinical criteria for HDGC.
• Patients willing to undergo at least one upper GI endoscopy with random biopsies according to Cambridge biopsy protocol.

You may not qualify if:

• Patients who decline evaluation with endoscopy either as a screening or surveillance tool
• Patients on clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

MRC Cancer Unit

Cambridge, United Kingdom

Location

Related Publications (4)

• van der Post RS, Vogelaar IP, Carneiro F, Guilford P, Huntsman D, Hoogerbrugge N, Caldas C, Schreiber KE, Hardwick RH, Ausems MG, Bardram L, Benusiglio PR, Bisseling TM, Blair V, Bleiker E, Boussioutas A, Cats A, Coit D, DeGregorio L, Figueiredo J, Ford JM, Heijkoop E, Hermens R, Humar B, Kaurah P, Keller G, Lai J, Ligtenberg MJ, O'Donovan M, Oliveira C, Pinheiro H, Ragunath K, Rasenberg E, Richardson S, Roviello F, Schackert H, Seruca R, Taylor A, Ter Huurne A, Tischkowitz M, Joe ST, van Dijck B, van Grieken NC, van Hillegersberg R, van Sandick JW, Vehof R, van Krieken JH, Fitzgerald RC. Hereditary diffuse gastric cancer: updated clinical guidelines with an emphasis on germline CDH1 mutation carriers. J Med Genet. 2015 Jun;52(6):361-74. doi: 10.1136/jmedgenet-2015-103094. Epub 2015 May 15.

  PMID: 25979631 BACKGROUND

• Mi EZ, Mi EZ, di Pietro M, O'Donovan M, Hardwick RH, Richardson S, Ziauddeen H, Fletcher PC, Caldas C, Tischkowitz M, Ragunath K, Fitzgerald RC. Comparative study of endoscopic surveillance in hereditary diffuse gastric cancer according to CDH1 mutation status. Gastrointest Endosc. 2018 Feb;87(2):408-418. doi: 10.1016/j.gie.2017.06.028. Epub 2017 Jul 6.

  PMID: 28688938 BACKGROUND

• Fewings E, Larionov A, Redman J, Goldgraben MA, Scarth J, Richardson S, Brewer C, Davidson R, Ellis I, Evans DG, Halliday D, Izatt L, Marks P, McConnell V, Verbist L, Mayes R, Clark GR, Hadfield J, Chin SF, Teixeira MR, Giger OT, Hardwick R, di Pietro M, O'Donovan M, Pharoah P, Caldas C, Fitzgerald RC, Tischkowitz M. Germline pathogenic variants in PALB2 and other cancer-predisposing genes in families with hereditary diffuse gastric cancer without CDH1 mutation: a whole-exome sequencing study. Lancet Gastroenterol Hepatol. 2018 Jul;3(7):489-498. doi: 10.1016/S2468-1253(18)30079-7. Epub 2018 Apr 27.

  PMID: 29706558 BACKGROUND

• Pappas A, Tan WK, Waldock W, Richardson S, Tripathi M, Januszewicz W, Roberts G, O'Donovan M, Fitzgerald RC, di Pietro M. Single-bite versus double-bite technique for mapping biopsies during endoscopic surveillance for hereditary diffuse gastric cancer: a single-center, randomized trial. Endoscopy. 2021 Mar;53(3):246-253. doi: 10.1055/a-1201-3125. Epub 2020 Jul 17.

  PMID: 32679601 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Massimiliano di Pietro, MD

  MRC Cancer Unit.University of Cambridge.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Scientist. Consultant Gastroenterologist.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: October 12, 2017
• Primary Completion: December 13, 2018
• Study Completion: December 13, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)