ProCHADA: Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05605873
Collaborator
(none)
46
2
15.5
23
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    46 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus
    Actual Study Start Date :
    Sep 16, 2022
    Actual Primary Completion Date :
    Oct 16, 2022
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    2. 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.

    3. Describe their therapeutic management [Year5]

      This outcome corresponds to the Proposed treatments (local excision, abdominal-perineal amputation, neoadjuvant treatment, adjuvant treatment, etc.).

    4. Compare prognosis by clinical and histological form [Year5]

      This outcome corresponds to the Mortality rate by clinical and histological form.

    5. Search for prognostic factors of severity in all forms [Year5]

      This outcome corresponds to the Prognostic factors of severity for all forms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014
    2 Centre hospitalo-universitaire de Cochin-Port Royal Paris France

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Study Director: Vincent De PARADES, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05605873
    Other Study ID Numbers:
    • ProCHADA
    First Posted:
    Nov 4, 2022
    Last Update Posted:
    Nov 10, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2022