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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04792892
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, 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.


Condition or disease Intervention/treatment
Anal Cancer Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly diagnosed anal cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-No informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792892


Contacts
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Contact: Eva Angenete 0760514441 eva.angenete@vgregion.se

Locations
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Sweden
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, Sweden, SE 416 85
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
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Responsible Party: Eva Angenete, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04792892    
Other Study ID Numbers: ANCA II
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Anus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases