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Early Detection of Relapse in Ovarian Cancer Using Capillary Home-sampling and a Protein Biomarker Test

NCT06445621 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2024-06-06

No results posted yet for this study

Summary

PURPOSE/AIMS There is no consensus on optimal follow-up after ovarian cancer. A recent study demonstrated eight months prolonged survival in patients with complete surgical resection. Hence, it is crucial to detect relapses early, when the tumor burden is limited.

The research group have previously identified a plasma protein panel with high accuracy in detecting ovarian cancer at diagnosis and follow-up. The aim with this feasibility study is to validate the panel for its' capacity to detect early relapse in symptom-free patients in a user-friendly non-invasive way i.e. a home-administered capillary sampling. The results will be the foundation for a forthcoming national prospective randomized trial.

METHODS The study is designed as a prospective cohort study including women in the control program after ovarian cancer in Uppsala and Umeå, Sweden. The study participants should have no evidence of disease after primary treatment or after relapse. In addition to standard follow-up, they will be asked to take a capillary home-sample (blood-test from finger) every second month during one year or until relapse. The result of the test will not affect treatment, but solely be used for research purposes.

IMPORTANCE The study aims to clarify following issues:

1. Calibration of the risk score in capillary blood samples.
2. Evaluation of the logistics in home-sampling.
3. Evaluation of the acceptability (reasons of drop-out etc.) of home-sampling by structured interviews of a sample of study participants.

CLINICAL SIGNIFICANCE The hypothesis behind the study is that more frequent analysis of a protein panel specific for ovarian cancer, will lead to earlier detection of relapse, earlier treatment and a better prognosis. Additionally, in the future the vision is that women may choose between different ways of follow-up depending on individual risk factors, personal preferences and logistic reasons. In the long-term the results of the applicability of home-administered blood sampling from this study can be useful in other patient groups as well.

Conditions

Sponsors & Collaborators

  • Norrlands Universitetssjukhus, Umea, Sweden

    collaborator UNKNOWN

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Karin Stålberg, A/ Professor · Uppsala University Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445621 on ClinicalTrials.gov