ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer (ANCAII)

December 7, 2023 updated by: Eva Angenete, Sahlgrenska University Hospital, Sweden

Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.

The aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE 416 85
        • Recruiting
        • Dept. of Surgery, Sahlgrenska University Hospital/Ostra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed anal cancer

Description

Inclusion Criteria:

  • Age > 18 years
  • Anal squamous carcinoma diagnosed within the last 2 months

Exclusion Criteria:

-No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a new diagnosis of anal cancer
All patients identified at our national tumour board will be offered to participate
Other: Questionnaires
Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: 3 months after diagnosis
Health related QoL at
3 months after diagnosis
Urinary function
Time Frame: 3 months after diagnosis
Evaluate urinary dysfunction
3 months after diagnosis
Bowel function
Time Frame: 3 months after diagnosis
Evaluate bowelfunction
3 months after diagnosis
Sexual function
Time Frame: 3 months after diagnosis
Evaluate sexual function
3 months after diagnosis
Toxicity related to treatment
Time Frame: 3 months after diagnosis
Number of patients with severe toxicity from the chemoradiotherapy
3 months after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: 12 months after diagnosis
QoL measured on a 7 point likert scale at 12 months
12 months after diagnosis
Urinary function
Time Frame: 12 months after diagnosis
Urinary dysfuntion measured as incontinence at 12 months
12 months after diagnosis
Bowel function
Time Frame: 12 months after diagnosis
Bowel dysfunction measured at 12 months
12 months after diagnosis
Sexual function
Time Frame: 12 months after diagnosis
Sexual dysfunction measured at 12 months
12 months after diagnosis
QoL
Time Frame: 3 years after diagnosis
QoL measured on a 7 point likert scale at 3 years
3 years after diagnosis
Urinary function
Time Frame: 3 years after diagnosis
Urinary function at 3 years
3 years after diagnosis
Bowel funcction
Time Frame: 3 years after diagnosis
Bowel dysfunction at 3 years
3 years after diagnosis
Sexual function
Time Frame: 3 years after diagnosis
Sexual dysfunction at 3 years
3 years after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCA II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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