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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| Vejle Hospital | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical response | Rate of complete response to primary treatment as defined by clinical and radiological evaluation | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark | |||
| Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39761919 | Derived | Storm KS, Spindler KLG, Persson GF, Kronborg C, Serup-Hansen E. Lower urinary tract sub-structures as predictors of late urinary toxicity in concurrent chemo-radiotherapy for anal cancer. Radiother Oncol. 2025 Mar;204:110708. doi: 10.1016/j.radonc.2025.110708. Epub 2025 Jan 4. |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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Tissue from the primary tumor and pre-treatment and consecutive blood samples are collected for a prospective biomarker evaluation
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 |
| Herlev |
| Denmark |
| Vejle Hospital | Vejle | 7100 | Denmark |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |