Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus

Active, not recruiting

• Conditions: Anal Adenocarcinoma

• Registration Number: NCT05605873
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-16
• Status Verified: 2022-10
• Primary Completion: 2022-10-16
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-04
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of mortality at 1 year, estimated using a survival curve	Year1	This outcome corresponds to the 1 year mortality rates after diagnosis of adenocarcinoma of the anus.
Risk of mortality at 5 years, estimated using a survival curve	Year5	This outcome corresponds to the 5 year mortality rates after diagnosis of adenocarcinoma of the anus.

Secondary Outcome Measures

Name	Time	Method
Search for prognostic factors of severity in all forms	Year5	This outcome corresponds to the Prognostic factors of severity for all forms.
Adaptaion of the therapeutic management according to the clinical and histological form	Year5	This outcome corresponds to the Proposed treatments (local excision, abdominoperineal amputation, neoadjuvant treatment, adjuvant treatment, etc.) according to the clinical and histological form.
Describe the various anatomical, etiological and histological forms	Year5	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.
Describe their therapeutic management	Year5	This outcome corresponds to the Proposed treatments (local excision, abdominal-perineal amputation, neoadjuvant treatment, adjuvant treatment, etc.).
Compare prognosis by clinical and histological form	Year5	This outcome corresponds to the Mortality rate by clinical and histological form.

Trial Locations

Locations (2)

Centre hospitalo-universitaire de Cochin-Port Royal; 🇫🇷 Paris, France

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France