Clinical trial · Observational
Early Detection of Relapse in Ovarian Cancer Using Capillary Home-sampling and a Protein Biomarker Test
Early Detection of Relapse in Ovarian Cancer Using Capillary Home-sampling and a Multiplex Protein Biomarker Test - a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Women in control program after ovarian/fallopian/primary peritoneal cancer
- description
- Study population; Inclusion criteria: * ≥18 years of age * Included in the control program for ovarian/fallopian/primary peritoneal cancer at Uppsala University Hospital, or in Norrlands University Hospital, Sweden * Within 3 years after completed primary treatment for stage III-IV EOC, or after treatment for relapse * No evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination). * Patients on maintenance therapy (PARP-inhibitor, bevazicumab) can be included. Exlusion: Other cancer diagnosis within 2 years (except squamous skin cancer or basalioma). Non-Swedish speaking. Not able to understand instructions.
Primary outcomes (2)
- measure
- Accuracy of capillary home-sampling to detect recurrence
- timeFrame
- From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
- description
- Accuracy (sensitivity/specificity) of the protein panel to detect recurrence
- measure
- Calibration/validation of the risk score in capillary blood samples
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDEnroth S, Ivansson E, Lindberg JH, Lycke M, Bergman J, Reneland A, Stalberg K, Sundfeldt K, Gyllensten U. Data-driven analysis of a validated risk score for ovarian cancer identifies clinically distinct patterns during follow-up and treatment. Commun Med (Lond). 2022 Oct 1;2:124. doi: 10.1038/s43856-022-00193-6. eCollection 2022. PMID 36196264
- BACKGROUNDEnroth S, Berggrund M, Lycke M, Broberg J, Lundberg M, Assarsson E, Olovsson M, Stalberg K, Sundfeldt K, Gyllensten U. High throughput proteomics identifies a high-accuracy 11 plasma protein biomarker signature for ovarian cancer. Commun Biol. 2019 Jun 20;2:221. doi: 10.1038/s42003-019-0464-9. eCollection 2019. PMID 31240259