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

October 5, 2022 updated by: Karen-Lise Garm Spindler, Aarhus University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Karen-Lise G Spindler, DMSc, PhD
  • Phone Number: +4591167244 +4591167244
  • Email: k.g.spindler@rm.dk

Study Contact Backup

  • Name: Karen-Lise G Spindler, Professor
  • Phone Number: +4591167244 +4591167244
  • Email: k.g.spindler@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital
      • Herlev, Denmark
        • Recruiting
        • Herlev Hospital
        • Contact:
          • Eva S Hansen
      • Vejle, Denmark, 7100
        • Recruiting
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete clinical response
Time Frame: 3 years
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
Time Frame: 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.
2 weeks after the last day of therapy
Late toxicity evaluation by CTCAE
Time Frame: 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.
1 and 3 years post treatment
Quality of life assessed by the EORTC QoL questionaires
Time Frame: 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.
2 weeks, 1 and 3 years post therapy
Prognostic value of ctDNA
Time Frame: 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)
At time of treatment completion, an average of 30 days, 1 and 3 years post therapy
Incidence of pelvis fractures
Time Frame: 1 and 3 years post therapy
Frequency of pelvic insufficience fractures at MRI scans
1 and 3 years post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Herlev Hospital
Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

December 26, 2018

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFE-1523

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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