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

NCT06445621 | Recruiting

• 1 other identifier: FOU2024-00132
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

ovarian cancer; follow-up; biomarker; protein

Outcome Measures

Primary Outcomes (2)

• Accuracy of capillary home-sampling to detect recurrence

  Accuracy (sensitivity/specificity) of the protein panel to detect recurrence

  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

• Calibration/validation of the risk score in capillary blood samples

  Analyses of the optimal protein panel to detect recurrence. Calculation of risk score/cut-off value for recurrence (ROC-curve)

  Capillary blood samples collected monthly for one year or until relapse

Secondary Outcomes (2)

• Evaluate the logistics in home-sampling (patients' instructions, registration, communication.)

  Monthly short questionnaire and longer questionnaire at end-of study, maximum one year.

• Evaluation of acceptability

  Interviews after end of study, (after first relapse, drop-out or end-of-study) maximum one year.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants are women included in the control program for ovarian/fallopian/primary peritoneal cancer at Uppsala University Hospital, Uppsala or in Norrlands University Hospital, Umeå, Sweden, . They should have been treated within 3 years after primary stage III-IV epithelial ovarian cancer (or diagnoses above), or within 3 years after treatment for relapse. Study participants should have no evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination) at inclusion.

You may qualify if:

• ≥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).

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Norrlands Universitetssjukhus, Umea, Sweden: collaborator

Study Sites (1)

Norrlands University Hospital

Umeå, Sweden

RECRUITING

Related Publications (2)

• Enroth 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 BACKGROUND

• Enroth 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

capillary blood sample, venous blood sample

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Karin Stålberg, A/ Professor

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Stålberg, A/ Professor

CONTACT

+46186111577; karin.stalberg@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 6, 2024
• Study Start: May 30, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

SE (1)