Anal CancerPLAN-ANCT05570279
PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark
An observational study of Anal Cancer, run by Aarhus University Hospital at 3 sites in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- How many people
- 314 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Apr 2016to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.
Who may be able to join
- Age ≥ 18
- Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy
- Written and oral consent
Who cannot join
- Contraindication to blood sampling or MRI scans (substudy 1 and 2)
- Other malignant disease within 5 years except from basal cell carcinomas
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, 8000
Herlev Hospital
Herlev
Vejle Hospital
Vejle, 7100
About this study
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
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.
- Conditions
- Anal Cancer
- Medical subject headings
- Anus Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response
Rate of complete response to primary treatment as defined by clinical and radiological evaluation
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 2 weeks after the last day of therapy
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.
Measured: 1 and 3 years post treatment
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.
Measured: 2 weeks, 1 and 3 years post therapy
Prognostic value of ctDNA
Measurement of circulating tumor DNA (in copies per ML)
Measured: At time of treatment completion, an average of 30 days, 1 and 3 years post therapy
Incidence of pelvis fractures
Frequency of pelvic insufficience fractures at MRI scans
Measured: 1 and 3 years post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Apr 2016
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Vejle Hospital
- Responsible party
- Principal investigator, Karen-Lise Garm Spindler, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570279
- Sponsor's protocol ID
- KFE-1523
- Acronym
- PLAN-A
- Status last verified
- Aug 2024
- First submitted
- 26 Dec 2018
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Storm KS, Spindler KLG, Persson GF, Kronborg C, Serup-Hansen E. Lower urinary tract sub-structures as predictors of late urinary toxicity in concurrent chemo-radiotherapy for anal cancer. Radiother Oncol. 2025 Mar;204:110708. doi: 10.1016/j.radonc.2025.110708. Epub 2025 Jan 4.
PubMed 39761919
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05570279
- Acronym / sponsor ID
- PLAN-A / KFE-1523
- Conditions
- Anal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital, Vejle Hospital
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients eligible for radiotherapy for SCCA in Denmark will be offered inclusion.
Key inclusion criteria (3 listed)
- Age ≥ 18
- Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy
- Written and oral consent
Key exclusion criteria (2 listed)
- Contraindication to blood sampling or MRI scans (substudy 1 and 2)
- Other malignant disease within 5 years except from basal cell carcinomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete clinical response
Time frame: 3 years
Rate of complete response to primary treatment as defined by clinical and radiological evaluation
5 secondary outcomes
Early toxicity evaluation by CTCAE
Time frame: 2 weeks after the last day of therapy
Late toxicity evaluation by CTCAE
Time frame: 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
Prognostic value of ctDNA
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 39761919Storm KS, Spindler KLG, Persson GF, Kronborg C, Serup-Hansen E. Lower urinary tract sub-structures as predictors of late urinary toxicity in concurrent chemo-radiotherapy for anal cancer. Radiother Oncol. 2025 Mar;204:110708. doi: 10.1016/j.radonc.2025.110708. Epub 2025 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Aarhus University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical response (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.