Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus (ProCHADA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anal Adenocarcinoma

• Study Type: Observational
• Enrollment (Anticipated): 46

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph
  • Paris, France
    • Centre hospitalo-universitaire de Cochin-Port Royal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the various anatomical, etiological and histological forms	This outcome corresponds to the classification 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 (mucinous, intestinal, glandular adenocarcinoma and primary or secondary Paget's disease) forms.	Year5
Adaptaion of the therapeutic management according to the clinical and histological form	This outcome corresponds to the Proposed treatments (local excision, abdominoperineal amputation, neoadjuvant treatment, adjuvant treatment, etc.) according to the clinical and histological form.	Year5
Describe their therapeutic management	This outcome corresponds to the Proposed treatments (local excision, abdominal-perineal amputation, neoadjuvant treatment, adjuvant treatment, etc.).	Year5
Compare prognosis by clinical and histological form	This outcome corresponds to the Mortality rate by clinical and histological form.	Year5
Search for prognostic factors of severity in all forms	This outcome corresponds to the Prognostic factors of severity for all forms.	Year5

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Study Director: Vincent De PARADES, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): October 16, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: ProCHADA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No