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

Recruiting

• Conditions: Anal Cancer
• Interventions: Other: Questionnaires

• Registration Number: NCT04792892
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-11
• Study Start: 2021-08-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2025-04-01
• Study Completion: 2035-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

-No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a new diagnosis of anal cancer	Questionnaires	All patients identified at our national tumour board will be offered to participate

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Urinary function	3 years after diagnosis	Urinary function at 3 years
Bowel function	12 months after diagnosis	Bowel dysfunction measured at 12 months
Sexual function	3 years after diagnosis	Sexual dysfunction at 3 years
Bowel funcction	3 years after diagnosis	Bowel dysfunction at 3 years
QoL	3 years after diagnosis	QoL measured on a 7 point likert scale at 3 years

Trial Locations

Locations (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden