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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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).

Locations
Other Locations
Sweden
Norrlands University Hospital
RECRUITING
Umeå
Contact Information
Primary
Karin Stålberg, A/ Professor
karin.stalberg@uu.se
+46186111577
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2026-05
Participants
Target number of participants: 125
Treatments
Women in control program after ovarian/fallopian/primary peritoneal cancer
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.
Related Therapeutic Areas
Sponsors
Leads: Uppsala University Hospital
Collaborators: Norrlands Universitetssjukhus, Umea, Sweden

This content was sourced from clinicaltrials.gov

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