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Anal CancerANCANCT02546973

Quality of Life in Patients With Anal Cancer

An observational study of Anal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A national study of a three year cohort consisting of all patients diagnosed with anal cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. Read more about this study

Who is it for?
Any age
Conditions the study is for
Anal Cancer
How many people
300 participants
Where
1 siteSweden
Study dates
Sep 2015to May 2024
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with anal cancer diagnosed 2011-2013

Who may be able to join

  • All patients registered with a diagnosis of anal cancer in either the Patient registry or the Cancer Registry during 2011 - 2013.

Who cannot join

  • No informed consent received for participation in the questionnaire part of the study.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Dept. of Surgery, Sahlgrenska University Hospital/Ostra

    Gothenburg, SE 416 85

Other trials in Sweden

About this study

Official title: ANCA - A Registry Based Study of Clinical Results and Health Related Quality of Life in Patients After Treatment for Anal Cancer

A national study of a three year cohort consisting of all patients diagnosed with anal cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All out- and inpatient visits with diagnoses, admission dates and discharge dates will be requested including.

Patient documentation from the concerned hospitals will be collected and data on the details of the treatment collected retrospectively in a standardised fashion using a clinical record form.

Read more

Comorbidity will be calculated using data from the Patient Registry using all main and co-diagnoses 2 years prior and then at least two years after treatment cessation.

Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years after index treatment.

Read the detailed description

Squamous cell carcinoma of the anus or "anal cancer" is an uncommon disease in the Western world. In Sweden approximately 100 patients are diagnosed each year. Most patients are treated by chemotherapy and radiation, but a small subgroup of non-responders and patients with recurrent disease undergo abdominoperineal excision with a permanent colostomy. In most reports of results these patients have a worse prognosis and a higher risk of local recurrence than anal cancer as a group(1, 2), possibly a result of a selection bias. Recently the results in a large Nordic cohort were presented, indicating that a further factor connected with successful outcome was that the patient was included in a treatment protocol(3).

A small number of patients with very small cancers are operated on primarily. This is especially true for anal margin tumours(4). However, for the most part patients will be primarily treated with radiotherapy, as their curative treatment.

In Sweden the treatment has been centralised for many years. The radiotherapy is normally a long course therapy with many smaller doses resulting in a high dose of radiation. There are well known complications such as skin problems and to some extent chronic radiation effects on deeper structures, which can result in functional side effects. If the treatment includes an abdominoperineal excision, the effects of a colostomy on quality of life as well as functional aspects of this surgical procedure are largely unknown in this group of patients. In our research group we have earlier studied large cohorts of patients who have undergone abdominoperineal excision for rectal cancer, and also unselected groups of patients with rectal cancer, studying both functional aspects and quality of life using detailed questionnaires (5, 6). Further we have results on quality of life from a cohort of Swedish inhabitants, representing men and women aged 30 to 90 years. The majority of the questions in these questionnaires are similar making comparisons possible.

In other studies within the SSORG network we have used the "Steineck concept" to investigate patient experiences of health, functional results and quality of life (7-11). We use specific questionnaires with detailed questions about experiences and symptoms asking about severity and duration as well as questions on socioeconomic functioning and life style factors (12, 13). Our experience is that patients are motivated to answer such questionnaires, with a compliance at 3 months >90% and at 12 months >85%.

Conditions
Anal Cancer
Medical subject headings
Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02546973
Study groupRoleWhat they receive
Patients with anal cancerAll patients with anal cancer during 2011-2013 will be asked to participate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HRQL in patient's with anal cancer 3 years after diagnosis

    To determine HRQL in patient's with anal cancer 3 years after diagnosis using a thorough questionnaire

    Measured: 3 years

Secondary outcomes (11)
  1. HRQL in patient's with anal cancer 6 years after diagnosis Functional aspects and symptoms

    To determine HRQL in patient's with anal cancer 3 years after diagnosis using a thorough questionnaire

    Measured: 6 years

  2. Comorbidity in the cohort prior to the diagnosis anal cancer

    Measured: 3 years

  3. Post-treatment morbidity in patients treated for anal cancer

    Measured: 3 years

  4. Type and number of surgical procedures in the patient population treated for anal cancer

    Measured: 6 years

  5. Accumulated length of hospital stay

    Measured: 6 years

  6. Differences in morbidity related to different treatments regimes

    Measured: 3 and 6 yeras

  7. Complete health economic analysis of resource consumption

    Measured: 6 years

  8. Mortality after anal cancer treatment

    Measured: 3 and 6 years

  9. Patient related personal factors that may affect HRQL measured by questionnaires

    Measured: 3 years

  10. Effect of complications on the patient's socioeconomic situation

    Measured: 3 years

  11. HRQL (measured by questionnaires) differences between patient groups such as age, gender and educational level

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

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
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02546973
Sponsor's protocol ID
ANCA
Acronym
ANCA
Status last verified
Dec 2023
First submitted
26 Aug 2015
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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 1 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: status not confirmed, 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?

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?

HRQL in patient's with anal cancer 3 years after diagnosis (time frame: 3 years). 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.

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