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

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.

Eligibility

Inclusion Criteria:

* ≥18 years of age
* Included in the control program for ovarian/fallopian/primary peritoneal cancer at at Uppsala University Hospital, Uppsala or in Norrlands University Hospital, Umeå,
* Within 3 years after completed primary treatment for stage III-IV epithelial ovarian cancer, or after treatment for relapse
* No evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination).

Exclusion Criteria:

* Other cancer diagnosis within 2 years (except squamous skin cancer or basalioma).
* Non-Swedish speaking.
* Not able to understand instructions.

Conditions4

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