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Trial Title:
PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark
NCT ID:
NCT05570279
Condition:
Anal Cancer
Conditions: Official terms:
Anus Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
The study is a prospective registration of treatment related-, toxicity-, Quality of
life- and outcome data from patients treated in Denmark with radiotherapy for squamous
cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group
(DACG).
Substudy one: A prospective biobank is collected with the purpose to identify predictive
and prognostic markers for outcome.
Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience
fractures at one year post chemoradiotherapy.
Criteria for eligibility:
Study pop:
All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18
- Squamous cell carcinoma of the anus, and indication for curatively intended
radiotherapy
- Written and oral consent
Exclusion Criteria:
- Contraindication to blood sampling or MRI scans (substudy 1 and 2)
- Other malignant disease within 5 years except from basal cell carcinomas
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Zip:
8000
Country:
Denmark
Facility:
Name:
Herlev Hospital
Address:
City:
Herlev
Country:
Denmark
Facility:
Name:
Vejle Hospital
Address:
City:
Vejle
Zip:
7100
Country:
Denmark
Start date:
April 1, 2016
Completion date:
April 1, 2026
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Herlev Hospital
Agency class:
Other
Collaborator:
Agency:
Vejle Hospital
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570279
