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NCT Number: NCT05570279

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complete clinical response

    Time frame: 3 years

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

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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)

  5. Incidence of pelvis fractures

    Time frame: 1 and 3 years post therapy

    Frequency of pelvic insufficience fractures at MRI scans

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Herlev Hospital
  • Vejle Hospital

Registry information

Official study 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

Acronym: PLAN-A

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Oct 6, 2022
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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