Clinical trial NCT06709872: A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline from Stage I Invasive Ovarian Cancer
Official title: Discriminating Borderline from Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stage I Ovarian Cancer
Borderline Ovarian Tumors
Keywords: Borderline ovarian tumors
stage I ovarian cancer
diagnostic
biomarkers
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor

Brief summary: The study aims to improve the diagnosis of ovarian cancer by distinguishing between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. Other than the traditional diagnostic biomarker CA125, the previous study TRANS-IOTA (translational-international ovarian tumor analysis; S51375/S59207), conducted by similar investigators, pointed at biomarkers like HE4, CA72.4, CA15.3, and CCL11, as potential markers to discriminate BOT from stage I cancer. BIOC is the follow-up study, which will include four additional promising biomarkers to expand the panel to nine. The investigators aim to confirm whether a subpanel of these nine biomarkers has diagnostic value. Such a biomarker signature would enhance the accuracy of distinguishing between BOT and stage I invasive ovarian cancer before surgery, leading to more precise treatment and improved patient outcomes.

Detailed description: The BIOC study, titled Discriminating Borderline from Stage I Invasive Ovarian Cancer, is a prospective, multicenter diagnostic biomarker study designed to refine diagnostic accuracy for ovarian cancer, specifically to differentiate between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. Existing diagnostic tools, such as the CA125 biomarker, are limited in their ability to provide precise differentiation in early stages, which is crucial for appropriate pre-surgical treatment planning. This study builds upon findings from the TRANS-IOTA (translational-international ovarian tumor analysis) study, expanding the biomarker panel to nine proteins, including CA125, HE4, CA72.4, and CCL11, alongside four additional biomarkers selected through systematic literature review.

The primary objective of BIOC is to develop a biomarker signature capable of distinguishing BOT from early-stage invasive ovarian cancer. This would allow for more accurate diagnoses either independently or in combination with ultrasound variables, thereby improving pre-surgical decision-making, reducing the need for second surgeries, and supporting more tailored treatments that improve patient outcomes. For younger patients with BOT, for instance, accurate differentiation could allow for fertility-preserving surgical options. A secondary aim of the study is to establish a robust database for BOT and stage I invasive ovarian cancer across Flanders (Belgium) and Europe, capturing detailed clinical, ultrasound, histological, and immune data that will guide future research and support gynecologists in refining their diagnostic approaches.

BIOC will be conducted across multiple hospitals in Flanders (Belgium) and a few European centers and aims to enroll 200 patients with BOT and 200 with stage I invasive ovarian cancer. Participants will primarily be recruited through gynecology ultrasound departments, where they will receive pre-surgical blood sampling and clinical evaluations. Recruitment will occur over three years, with the study concluding after a subsequent two-year analysis period, aiming for completion between 2028 and 2029.

By establishing a validated biomarker panel for early ovarian cancer diagnosis, BIOC has the potential to significantly enhance diagnostic accuracy and efficiency. This could transform the precision of preoperative assessments, reduce unnecessary invasive procedures, and improve overall treatment planning, thus enhancing patient outcomes and quality of life for those affected by ovarian cancer.

Eligibility criteria: Inclusion Criteria:

* Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  3. Ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor (subjective assessment)

Exclusion Criteria:

* Participants eligible for this Study must not meet any of the following criteria:

  1. Participants younger than 18 years old,
  2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
  3. Participants who refuse the preoperative transvaginal ultrasonography and/or blood sample
  4. Participants with known simultaneous and/or previous malignancies within five years prior to BIOC participation
  5. Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C)
  6. Participants who deny or withdraw the written informed consent

Primary outcomes:
measure: Diagnostic performance of biomarkers
timeFrame: After 12 months following the recruitment
Secondary outcomes:
measure: Database establishment
timeFrame: Start registering the data of patients in the database from the day of recruitment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flemish Brabant
Study officials:
affiliation: KU Leuven
name: An Coosemans
role: PRINCIPAL_INVESTIGATOR
References: