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

Anal Cancer Clinical Trial

— PLAN-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570279
• Other study ID #: KFE-1523
• Status: Recruiting
• Start date: April 1, 2016
• Est. completion date: April 1, 2026

Study information

• Verified date: October 2022
• Source: Aarhus University Hospital
• Contact: Karen-Lise G Spindler, DMSc, PhD
• Phone: +4591167244
• Email: k.g.spindler[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Herlev Hospital	Herlev
Denmark	Vejle Hospital	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Herlev Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clinical response	Rate of complete response to primary treatment as defined by clinical and radiological evaluation	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of pelvis fractures	Frequency of pelvic insufficience fractures at MRI scans	1 and 3 years post therapy