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

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ClinicalTrials.gov Identifier: NCT04792892
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date March 10, 2021
First Posted Date March 11, 2021
Last Update Posted Date October 19, 2021
Actual Study Start Date August 1, 2021
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2021)
  • QoL [ Time Frame: 3 months after diagnosis ]
    Health related QoL at
  • Urinary function [ Time Frame: 3 months after diagnosis ]
    Evaluate urinary dysfunction
  • Bowel function [ Time Frame: 3 months after diagnosis ]
    Evaluate bowelfunction
  • Sexual function [ Time Frame: 3 months after diagnosis ]
    Evaluate sexual function
  • Toxicity related to treatment [ Time Frame: 3 months after diagnosis ]
    Number of patients with severe toxicity from the chemoradiotherapy
Original Primary Outcome Measures
 (submitted: March 10, 2021)
  • QoL [ Time Frame: 3 months after diagnosis ]
    Health related QoL at
  • Urinary function [ Time Frame: 3 months after diagnosis ]
    Evaluate urinary dysfunction
  • Bowel function [ Time Frame: 3 months after diagnosis ]
    Evaluate bowelfunction
  • Sexual function [ Time Frame: 3 months after diagnosis ]
    Evaluate sexual function
  • Toxicity related to treatment [ Time Frame: 3 months after diagnosis ]
    Mainly bleeding, bowel function and fatigue
Change History
Current Secondary Outcome Measures
 (submitted: March 19, 2021)
  • QoL [ Time Frame: 12 months after diagnosis ]
    QoL measured on a 7 point likert scale at 12 months
  • Urinary function [ Time Frame: 12 months after diagnosis ]
    Urinary dysfuntion measured as incontinence at 12 months
  • Bowel function [ Time Frame: 12 months after diagnosis ]
    Bowel dysfunction measured at 12 months
  • Sexual function [ Time Frame: 12 months after diagnosis ]
    Sexual dysfunction measured at 12 months
  • QoL [ Time Frame: 3 years after diagnosis ]
    QoL measured on a 7 point likert scale at 3 years
  • Urinary function [ Time Frame: 3 years after diagnosis ]
    Urinary function at 3 years
  • Bowel funcction [ Time Frame: 3 years after diagnosis ]
    Bowel dysfunction at 3 years
  • Sexual function [ Time Frame: 3 years after diagnosis ]
    Sexual dysfunction at 3 years
Original Secondary Outcome Measures
 (submitted: March 10, 2021)
  • QoL [ Time Frame: 12 months after diagnosis ]
    QoL at 12 months
  • Urinary function [ Time Frame: 12 months after diagnosis ]
    Urinary dyscuntion measured at 12 months
  • Bowel function [ Time Frame: 12 months after diagnosis ]
    Bowel dysfunction measured at 12 months
  • Sexual function [ Time Frame: 12 months after diagnosis ]
    Sexual dysfunction measured at 12 months
  • QoL [ Time Frame: 3 years after diagnosis ]
    QoL measured at 3 years
  • Urinary function [ Time Frame: 3 years after diagnosis ]
    Urinary function at 3 years
  • Bowel funcction [ Time Frame: 3 years after diagnosis ]
    Bowel dysfunction at 3 years
  • Sexual function [ Time Frame: 3 years after diagnosis ]
    Sexual dysfunction at 3 years
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
Official Title ANCA II - Quality of Life and Functional Outcome in Patients With 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with newly diagnosed anal cancer
Condition Anal Cancer
Intervention Other: Questionnaires
Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months
Study Groups/Cohorts Patients with a new diagnosis of anal cancer
All patients identified at our national tumour board will be offered to participate
Intervention: Other: Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 10, 2021)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2034
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-No informed consent

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eva Angenete 0760514441 eva.angenete@vgregion.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04792892
Other Study ID Numbers ANCA II
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Eva Angenete, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Not Provided
Investigators Not Provided
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date October 2021