Young Survivors at Kantonsspital Aarau, Switzerland

NCT04811794 | Recruiting

• 1 other identifier: AO_2020-00012
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. The clinical data are generated during regular follow-up care visits, the collection starts directly after completion of treatment and is longitudinally.

Conditions

Childhood Cancer; Late Effects

Keywords

Childhood Cancer; Survivor; Late Effects; CTCAE

Outcome Measures

Primary Outcomes (1)

• Test results to assess organ-specific late effects (example of cardiac health)

  Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects

  at recruitment or 2016 onwards, whichever comes first

Secondary Outcomes (5)

• Test results to assess organ-specific late effects (example of cardiac health)

  annually from recruitment or 2016 onwards, whichever comes first

• Sociodemographic and socioeconomic characteristics (e.g. age at clinical examination, gender, education or working situation, living situation)

  annually from recruitment or 2016 onwards, whichever comes first

• Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects

  annually from recruitment or 2016 onwards, whichever comes first

• Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol)

  at recruitment or 2016 onwards, whichever comes first

• Treatment-related data (e.g. cumulative doses of chemotherapy and radiotherapy, surgery, hematopoietic stem cell transplantation )

  at recruitment or 2016 onwards, whichever comes first

Study Arms (2)

Group A (largest part of the cohort)

Children, adolescents, and adults who are still in follow-up care (data are collected retrospectively until 2016 at the most)

Other: Physical examination, diagnostic tests, laboratory tests; Other: Personal history

Group B (very small part of the cohort)

Children, adolescents, and adults who left follow-up care (data are collected retrospectively until 2016 at the most)

Other: Physical examination, diagnostic tests, laboratory tests; Other: Personal history

Interventions

Physical examination, diagnostic tests, laboratory tests OTHER

Physical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system.

Group A (largest part of the cohort); Group B (very small part of the cohort)

Personal history OTHER

Personal history on diagnosis, treatment, and socioeconomic factors

Group A (largest part of the cohort); Group B (very small part of the cohort)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all children, adolescents and adults who have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau and who have completed their treatment and have entered follow-up care.

You may qualify if:

• Group A:
• Children and adolescents who:
• have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau,
• have been diagnosed at age 0-18 years,
• are still in regular follow-up care at the Kantonsspital Aarau,
• have finished cancer treatment and entered follow-up care, and
• signed informed consent
• Group B:
• Adolescents and adults who:
• are not in regular follow-up care anymore

You may not qualify if:

• Childhood Cancer Survivors who:
• are in a palliative situation or
• have not given consent for further use of medical data

Sponsors & Collaborators

• Kantonsspital Aarau: lead

Study Sites (1)

Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau

Aarau, Switzerland

RECRUITING

Related Publications (1)

• Otth M, Drozdov D, Hugli C, Scheinemann K. Young Survivors at KSA: registry for standardised assessment of long-term and late-onset health events in survivors of childhood and adolescent cancer-a study protocol. BMJ Open. 2021 Dec 3;11(12):e053749. doi: 10.1136/bmjopen-2021-053749.

  PMID: 34862296 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Restraint, Physical; Health Records, Personal

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Medical Records; Records; Data Collection; Epidemiologic Methods

Central Study Contacts

Katrin Scheinemann, MD

CONTACT

+41628384909; katrin.scheinemann@ksa.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head of Pediatric Oncology-Hematology

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 15, 2021
• Primary Completion (Estimated): March 15, 2071
• Study Completion (Estimated): March 15, 2072
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)