Quality of Life in Patients With Anal Cancer
ANCA
ANCA - A Registry Based Study of Clinical Results and Health Related Quality of Life in Patients After Treatment for Anal Cancer
1 other identifier
observational
300
1 country
1
Brief Summary
A national study of a three year cohort consisting of all patients diagnosed with anal cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All out- and inpatient visits with diagnoses, admission dates and discharge dates will be requested including. Patient documentation from the concerned hospitals will be collected and data on the details of the treatment collected retrospectively in a standardised fashion using a clinical record form. Comorbidity will be calculated using data from the Patient Registry using all main and co-diagnoses 2 years prior and then at least two years after treatment cessation. Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years after index treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedDecember 8, 2023
December 1, 2023
8.7 years
August 26, 2015
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
HRQL in patient's with anal cancer 3 years after diagnosis
To determine HRQL in patient's with anal cancer 3 years after diagnosis using a thorough questionnaire
3 years
Secondary Outcomes (11)
HRQL in patient's with anal cancer 6 years after diagnosis Functional aspects and symptoms
6 years
Comorbidity in the cohort prior to the diagnosis anal cancer
3 years
Post-treatment morbidity in patients treated for anal cancer
3 years
Type and number of surgical procedures in the patient population treated for anal cancer
6 years
Accumulated length of hospital stay
6 years
- +6 more secondary outcomes
Study Arms (1)
Patients with anal cancer
All patients with anal cancer during 2011-2013 will be asked to participate
Eligibility Criteria
Patients with anal cancer diagnosed 2011-2013
You may qualify if:
- All patients registered with a diagnosis of anal cancer in either the Patient registry or the Cancer Registry during 2011 - 2013.
You may not qualify if:
- No informed consent received for participation in the questionnaire part of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Angenete, M.D., Ph.D.
Sahlgrenska University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D., Ass. Prof.
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 11, 2015
Study Start
September 1, 2015
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
December 8, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share