Anal CancerANCAIINCT04792892
ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
An observational study of Anal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Questionnaires
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2021to 1 Apr 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with newly diagnosed anal cancer
Who may be able to join
- Age > 18 years
- Anal squamous carcinoma diagnosed within the last 2 months
Who cannot join
- -No informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
Eva Angenete, MD,PhD, +46313438410, eva.angenete@vgregion.se
About this study
Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.
The aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.
- Conditions
- Anal Cancer
- Being tested
- Questionnaires
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with a new diagnosis of anal cancer | All patients identified at our national tumour board will be offered to participate Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL
Health related QoL at
Measured: 3 months after diagnosis
Urinary function
Evaluate urinary dysfunction
Measured: 3 months after diagnosis
Bowel function
Evaluate bowelfunction
Measured: 3 months after diagnosis
Sexual function
Evaluate sexual function
Measured: 3 months after diagnosis
Toxicity related to treatment
Number of patients with severe toxicity from the chemoradiotherapy
Measured: 3 months after diagnosis
Secondary outcomes (8)
QoL
QoL measured on a 7 point likert scale at 12 months
Measured: 12 months after diagnosis
Urinary function
Urinary dysfuntion measured as incontinence at 12 months
Measured: 12 months after diagnosis
Bowel function
Bowel dysfunction measured at 12 months
Measured: 12 months after diagnosis
Sexual function
Sexual dysfunction measured at 12 months
Measured: 12 months after diagnosis
QoL
QoL measured on a 7 point likert scale at 3 years
Measured: 3 years after diagnosis
Urinary function
Urinary function at 3 years
Measured: 3 years after diagnosis
Bowel funcction
Bowel dysfunction at 3 years
Measured: 3 years after diagnosis
Sexual function
Sexual dysfunction at 3 years
Measured: 3 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Aug 2021
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792892
- Sponsor's protocol ID
- ANCA II
- Acronym
- ANCAII
- Status last verified
- Dec 2023
- First submitted
- 10 Mar 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
- ClinicalTrials.gov ID
- NCT04792892
- Acronym / sponsor ID
- ANCAII / ANCA II
- Conditions
- Anal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2035 (estimated)
- First posted
- 11 Mar 2021 (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.
Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.
The aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a new diagnosis of anal cancer | – | Other: QuestionnairesAll patients identified at our national tumour board will be offered to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed anal cancer
Key inclusion criteria (2 listed)
- Age > 18 years
- Anal squamous carcinoma diagnosed within the last 2 months
Key exclusion criteria (1 listed)
- -No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPatients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months | Other | Patients with a new diagnosis of anal cancer |
Primary outcome
QoL
Time frame: 3 months after diagnosis
Health related QoL at
Urinary function
Time frame: 3 months after diagnosis
Evaluate urinary dysfunction
Bowel function
Time frame: 3 months after diagnosis
Evaluate bowelfunction
Sexual function
Time frame: 3 months after diagnosis
Evaluate sexual function
Toxicity related to treatment
Time frame: 3 months after diagnosis
Number of patients with severe toxicity from the chemoradiotherapy
8 secondary outcomes
QoL
Time frame: 12 months after diagnosis
Urinary function
Time frame: 12 months after diagnosis
Bowel function
Time frame: 12 months after diagnosis
Sexual function
Time frame: 12 months after diagnosis
QoL
Time frame: 3 years after diagnosis
Urinary function
Time frame: 3 years after diagnosis
Bowel funcction
Time frame: 3 years after diagnosis
Sexual function
Time frame: 3 years after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 Sahlgrenska University Hospital at 1 site in Sweden.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Angenete (0760514441, eva.angenete@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL (time frame: 3 months after diagnosis). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.