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

Anal Cancer Clinical Trial

— ANCAII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792892
• Other study ID #: ANCA II
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: April 1, 2035

Study information

• Verified date: December 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Eva Angenete
• Phone: 0760514441
• Email: eva.angenete[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 1, 2035
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years
• Anal squamous carcinoma diagnosed within the last 2 months Exclusion Criteria: -No informed consent

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

Other:
• Questionnaires
Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months

Locations

Country	Name	City	State
Sweden	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL	Health related QoL at	3 months after diagnosis
Primary	Urinary function	Evaluate urinary dysfunction	3 months after diagnosis
Primary	Bowel function	Evaluate bowelfunction	3 months after diagnosis
Primary	Sexual function	Evaluate sexual function	3 months after diagnosis
Primary	Toxicity related to treatment	Number of patients with severe toxicity from the chemoradiotherapy	3 months after diagnosis
Secondary	QoL	QoL measured on a 7 point likert scale at 12 months	12 months after diagnosis
Secondary	Urinary function	Urinary dysfuntion measured as incontinence at 12 months	12 months after diagnosis
Secondary	Bowel function	Bowel dysfunction measured at 12 months	12 months after diagnosis
Secondary	Sexual function	Sexual dysfunction measured at 12 months	12 months after diagnosis
Secondary	QoL	QoL measured on a 7 point likert scale at 3 years	3 years after diagnosis
Secondary	Urinary function	Urinary function at 3 years	3 years after diagnosis
Secondary	Bowel funcction	Bowel dysfunction at 3 years	3 years after diagnosis
Secondary	Sexual function	Sexual dysfunction at 3 years	3 years after diagnosis