Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus

NCT05605873 | Unknown

• 1 other identifier: ProCHADA
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Adenocarcinoma of the anus is rare. It concerns less than 10% of anal cancers and its incidence is less than 0.2/100 000 inhabitants. Its management is not consensual and is most often derived by analogy with that of adenocarcinoma of the lower rectum. This is due to the rarity but also to the diversity of anatomical (anal margin, anal canal, lower rectum), etiological (primary glandular tumors or secondary to anal fistula, primary distant tumor and/or Crohn's disease) and histological forms (mucinous, intestinal, glandular adenocarcinomas and primary or secondary Paget's disease). Most of the literature consists of small case series and simple clinical cases in which the prognosis of these subforms has not been studied.

Conditions

Anal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Risk of mortality at 1 year, estimated using a survival curve

  This outcome corresponds to the 1 year mortality rates after diagnosis of adenocarcinoma of the anus.

  Year1

• Risk of mortality at 5 years, estimated using a survival curve

  This outcome corresponds to the 5 year mortality rates after diagnosis of adenocarcinoma of the anus.

  Year5

Secondary Outcomes (5)

• Describe the various anatomical, etiological and histological forms

  Year5

• Adaptaion of the therapeutic management according to the clinical and histological form

  Year5

• Describe their therapeutic management

  Year5

• Compare prognosis by clinical and histological form

  Year5

• Search for prognostic factors of severity in all forms

  Year5

Eligibility Criteria

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

Study Population

Patients with a diagnosis of adenocarcinoma of the anus between 01/01/2006 and 30/06/2022 in participating centers

You may qualify if:

• Patient over 18 years of age
• French-speaking patient
• Patient with a diagnosis of adenocarcinoma of the anus between 01/01/2006 and 30/06/2022 in participating centers

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection
• Patient objecting to the use of his data for this research

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Centre hospitalo-universitaire de Cochin-Port Royal

Paris, France

Location

Related Publications (5)

• Anwar S, Welbourn H, Hill J, Sebag-Montefiore D. Adenocarcinoma of the anal canal - a systematic review. Colorectal Dis. 2013 Dec;15(12):1481-8. doi: 10.1111/codi.12325.

  PMID: 23809885 BACKGROUND

• Lukovic J, Kim JJ, Liu ZA, Cummings BJ, Brierley JD, Wong RKS, Ringash JG, Dawson LA, Barry A, Krzyzanowska MK, Chen EX, Hedley DW, Quereshy FA, Swallow CJ, Gryfe RN, Kennedy ED, Easson AM, Hosni A. Anal Adenocarcinoma: A Rare Entity in Need of Multidisciplinary Management. Dis Colon Rectum. 2022 Feb 1;65(2):189-197. doi: 10.1097/DCR.0000000000002281.

  PMID: 34990422 BACKGROUND

• Wang Q, Fu J, Chen X, Cai C, Ruan H, Du J. What factors are associated with the poor prognosis of anal adenocarcinoma compared with low-lying rectal adenocarcinoma based on a population analysis: A propensity score matching study. PLoS One. 2019 Jul 30;14(7):e0219937. doi: 10.1371/journal.pone.0219937. eCollection 2019.

  PMID: 31361759 BACKGROUND

• Yasuhara M, Beppu N, Uchino M, Ikeuchi H, Matsuda I, Hirota S, Ikeda M, Tomita N. Adverse Oncologic Outcomes of Adenocarcinoma of the Anal Canal in Patients With Crohn's Disease. Dis Colon Rectum. 2021 Apr 1;64(4):409-419. doi: 10.1097/DCR.0000000000001874.

  PMID: 33394780 BACKGROUND

• Lee GC, Kunitake H, Stafford C, Bordeianou LG, Francone TD, Ricciardi R. High Risk of Proximal and Local Neoplasms in 2206 Patients With Anogenital Extramammary Paget's Disease. Dis Colon Rectum. 2019 Nov;62(11):1283-1293. doi: 10.1097/DCR.0000000000001487.

  PMID: 31567917 BACKGROUND

Study Officials

• Vincent De PARADES, MD

  Fondation Hôpital Saint-Joseph

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: September 16, 2022
• Primary Completion: October 16, 2022
• Study Completion: December 31, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-10

Locations

FR (2)