Clincosm LogoSign in Get a demo

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

Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05570279
Collaborator
Herlev Hospital (Other), Vejle Hospital (Other)
600
Enrollment
3
Locations
120
Anticipated Duration (Months)
200
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Apr 1, 2016
    Anticipated Primary Completion Date :
    Apr 1, 2026
    Anticipated Study Completion Date :
    Apr 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Complete clinical response [3 years]

      Rate of complete response to primary treatment as defined by clinical and radiological evaluation

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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)

    5. Incidence of pelvis fractures [1 and 3 years post therapy]

      Frequency of pelvic insufficience fractures at MRI scans

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Denmark 8000
    2 Herlev Hospital Herlev Denmark
    3 Vejle Hospital Vejle Denmark 7100

    Sponsors and Collaborators

    • Aarhus University Hospital
    • Herlev Hospital
    • Vejle Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen-Lise Garm Spindler, Professor, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT05570279
    Other Study ID Numbers:
    • KFE-1523
    First Posted:
    Oct 6, 2022
    Last Update Posted:
    Oct 6, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anus Neoplasms

    Study Results

    No Results Posted as of Oct 6, 2022