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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04792892

Acronym

ANCAII

Enrollment

600

Registered

2021-03-11

Start date

2021-08-01

Completion date

2035-04-01

Last updated

2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer

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.

Interventions

OTHERQuestionnaires

Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

-No informed consent

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Contacts

Primary ContactEva Angenete

eva.angenete@vgregion.se0760514441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026