PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clinical response | Rate of complete response to primary treatment as defined by clinical and radiological evaluation | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early toxicity evaluation by CTCAE | The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone. | 2 weeks after the last day of therapy | 
| Late toxicity evaluation by CTCAE | The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone. | 1 and 3 years post treatment | 
| Quality of life assessed by the EORTC QoL questionaires | European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QoL) questionnaire (QLQ) C30 (core). The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC (colorectal cancer) patients, which is designed to complement the EORTC QLQ-C30 questionnaire. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales. | 2 weeks, 1 and 3 years post therapy | 
| Prognostic value of ctDNA | Measurement of circulating tumor DNA (in copies per ML) | At time of treatment completion, an average of 30 days, 1 and 3 years post therapy | 
| Incidence of pelvis fractures | Frequency of pelvic insufficience fractures at MRI scans | 1 and 3 years post therapy |