Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus

Anal Adenocarcinoma Clinical Trial

— ProCHADA  

Official title:

Clinical, Histological and Prognostic Forms of Adenocarcinoma of the Anus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05605873
• Other study ID #: ProCHADA
• Status: Active, not recruiting
• Start date: September 16, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 31, 2023
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Anal Adenocarcinoma

Locations

Country	Name	City	State
France	Centre hospitalo-universitaire de Cochin-Port Royal	Paris
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Describe their therapeutic management	This outcome corresponds to the Proposed treatments (local excision, abdominal-perineal amputation, neoadjuvant treatment, adjuvant treatment, etc.).	Year5
Secondary	Compare prognosis by clinical and histological form	This outcome corresponds to the Mortality rate by clinical and histological form.	Year5
Secondary	Search for prognostic factors of severity in all forms	This outcome corresponds to the Prognostic factors of severity for all forms.	Year5