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NCT Number: NCT04792892

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

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.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location status: Recruiting

Location contact

Eva Angenete, MD,PhD

CONTACT

[email protected]

+46313438410

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-No informed consent

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. QoL

    Time frame: 3 months after diagnosis

    Health related QoL at

  2. Urinary function

    Time frame: 3 months after diagnosis

    Evaluate urinary dysfunction

  3. Bowel function

    Time frame: 3 months after diagnosis

    Evaluate bowelfunction

  4. Sexual function

    Time frame: 3 months after diagnosis

    Evaluate sexual function

  5. Toxicity related to treatment

    Time frame: 3 months after diagnosis

    Number of patients with severe toxicity from the chemoradiotherapy

Secondary outcomes

  1. QoL

    Time frame: 12 months after diagnosis

    QoL measured on a 7 point likert scale at 12 months

  2. Urinary function

    Time frame: 12 months after diagnosis

    Urinary dysfuntion measured as incontinence at 12 months

  3. Bowel function

    Time frame: 12 months after diagnosis

    Bowel dysfunction measured at 12 months

  4. Sexual function

    Time frame: 12 months after diagnosis

    Sexual dysfunction measured at 12 months

  5. QoL

    Time frame: 3 years after diagnosis

    QoL measured on a 7 point likert scale at 3 years

  6. Urinary function

    Time frame: 3 years after diagnosis

    Urinary function at 3 years

  7. Bowel funcction

    Time frame: 3 years after diagnosis

    Bowel dysfunction at 3 years

  8. Sexual function

    Time frame: 3 years after diagnosis

    Sexual dysfunction at 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Angenete

CONTACT

[email protected]

0760514441

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: ANCAII

Important dates

Study start
2021
Primary completion
2025
Study completion
2035
First posted
Mar 11, 2021
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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