PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark
PLAN-A
PLAN-A - Data- Bio-and Plan-bank Collection in Patients Treated With Radiotherapy for Squamous Cell Carcinoma of the Anus in Denmark - a DACG Cooperation
1 other identifier
observational
314
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 26, 2018
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 14, 2024
August 1, 2024
9 years
December 26, 2018
August 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Complete clinical response
Rate of complete response to primary treatment as defined by clinical and radiological evaluation
3 years
Secondary Outcomes (5)
Early toxicity evaluation by CTCAE
2 weeks after the last day of therapy
Late toxicity evaluation by CTCAE
1 and 3 years post treatment
Quality of life assessed by the EORTC QoL questionaires
2 weeks, 1 and 3 years post therapy
Prognostic value of ctDNA
At time of treatment completion, an average of 30 days, 1 and 3 years post therapy
Incidence of pelvis fractures
1 and 3 years post therapy
Eligibility Criteria
All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.
You may qualify if:
- Age ≥ 18
- Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy
- Written and oral consent
You may not qualify if:
- Contraindication to blood sampling or MRI scans (substudy 1 and 2)
- Other malignant disease within 5 years except from basal cell carcinomas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- Herlev Hospitalcollaborator
- Vejle Hospitalcollaborator
Study Sites (3)
Aarhus University Hospital
Aarhus, 8000, Denmark
Herlev Hospital
Herlev, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Biospecimen
Tissue from the primary tumor and pre-treatment and consecutive blood samples are collected for a prospective biomarker evaluation
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 26, 2018
First Posted
October 6, 2022
Study Start
April 1, 2016
Primary Completion
April 1, 2025
Study Completion
April 1, 2026
Last Updated
August 14, 2024
Record last verified: 2024-08