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Fistula-associated Anal Adenocarcinoma

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT05381324
Collaborator
(none)
1,004
Enrollment
280
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The fistula-associated anal adenocarcinoma is rare in patients suffering from anal fistulas. There is only little data available for this patient collective making characterization and management of this disease difficult. Late diagnosis and advanced tumor stage at diagnosis result in poor clinical outcome. It is the purpose of this study to evaluate patients clinically diagnosed with a FAAC and to further perform a histopathological characterization of the available tumor specimen.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patients receiving surgery for an anal fistula in the years 1999 to 2019 at a tertiary university referral hospital were included in the analysis. A retrospective review of patients' charts was performed. Patients suffering from FAAC were eligible for histopathological analysis including immunohistochemistry and molecular profiling.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1004 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Fistula-associated Anal Adenocarcinoma - a Twenty Years' Single-center Experience.
    Actual Study Start Date :
    Jan 1, 1999
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    May 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. fistula-associated anal adenocarcinoma (FAAC) [1999-2019]

      include and analyze all patients suffering from FAAC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • anal fistula
    Exclusion Criteria:
    • previous cancer of the anal canal

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Felix Harpain, Dr.med.univ., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT05381324
    Other Study ID Numbers:
    • 1258
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Fistula

    Study Results

    No Results Posted as of May 19, 2022