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

Active, not recruiting

• Conditions: Anal Cancer

• Registration Number: NCT05570279
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 314

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete clinical response	3 years	Rate of complete response to primary treatment as defined by clinical and radiological evaluation

Secondary Outcome Measures

Name	Time	Method
Early toxicity evaluation by CTCAE	2 weeks after the last day of therapy	The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.
Late toxicity evaluation by CTCAE	1 and 3 years post treatment	The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.
Quality of life assessed by the EORTC QoL questionaires	2 weeks, 1 and 3 years post therapy	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.
Prognostic value of ctDNA	At time of treatment completion, an average of 30 days, 1 and 3 years post therapy	Measurement of circulating tumor DNA (in copies per ML)
Incidence of pelvis fractures	1 and 3 years post therapy	Frequency of pelvic insufficience fractures at MRI scans

Trial Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark