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Anal AdenocarcinomaProCHADANCT05605873

Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus

An observational study of Anal Adenocarcinoma, run by Fondation Hôpital Saint-Joseph at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Adenocarcinoma
How many people
46 participants
Where
2 sitesFrance
Study dates
16 Sep 2022to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

  • Centre hospitalo-universitaire de Cochin-Port Royal

    Paris

Other trials in France

About this study

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Year1

  2. 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.

    Measured: Year5

Secondary outcomes (5)

  1. 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.

    Measured: Year5

  2. 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.

    Measured: Year5

  3. Describe their therapeutic management

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

    Measured: Year5

  4. Compare prognosis by clinical and histological form

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

    Measured: Year5

  5. Search for prognostic factors of severity in all forms

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

    Measured: Year5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start16 Sep 2022
  3. Primary completion16 Oct 2022
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605873
Sponsor's protocol ID
ProCHADA
Acronym
ProCHADA
Status last verified
Oct 2022
First submitted
31 Oct 2022
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 23809885

  • 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.

    PubMed 34990422

  • 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.

    PubMed 31361759

  • 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.

    PubMed 33394780

  • 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.

    PubMed 31567917

Questions about this trial

What is this clinical trial studying?

An observational study of Anal Adenocarcinoma, run by Fondation Hôpital Saint-Joseph at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of mortality at 1 year, estimated using a survival curve (time frame: Year1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605873, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

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