Clinical trial · Observational
PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete clinical response
- timeFrame
- 3 years
- description
- Rate of complete response to primary treatment as defined by clinical and radiological evaluation
Secondary outcomes (5)
- measure
- Early toxicity evaluation by CTCAE
- timeFrame
- 2 weeks after the last day of therapy
- description
- The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.
- measure
- Late toxicity evaluation by CTCAE
- timeFrame
- 1 and 3 years post treatment
- description
- The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDStorm 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. PMID 39761919