A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline from Stage I Invasive Ovarian Cancer

NCT06709872 | Active Not Recruiting DMC

• 2 other identifiers: S6984913583
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Ovarian Cancer; Borderline Ovarian Tumors

Keywords

Borderline ovarian tumors; stage I ovarian cancer; diagnostic; biomarkers

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of biomarkers

  Diagnostic performance of a protein-based biomarker or set of biomarkers that can discriminate between BOT and stage I invasive ovarian cancer in terms of area under the receiver operative characteristics curve (AUROC).

  After 12 months following the recruitment

Secondary Outcomes (1)

• Database establishment

  Start registering the data of patients in the database from the day of recruitment

Study Arms (2)

Borderline ovarian tumor cohort

Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT

stage I invasive ovarian cancer cohort

Patients with ultrasound discovery of a cyst on the ovary, suspicious for stage I invasive ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All females with female reproductive system as this study aims to improve diagnosis of ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor

You may qualify if:

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

You may not qualify if:

• Participants eligible for this Study must not meet any of the following criteria:
• Participants younger than 18 years old,
• 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
• Participants who refuse the preoperative transvaginal ultrasonography and/or blood sample
• Participants with known simultaneous and/or previous malignancies within five years prior to BIOC participation
• Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C)
• Participants who deny or withdraw the written informed consent

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum isolated from blood samples

MeSH Terms

Conditions

Ovarian Neoplasms; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• An Coosemans

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory at KU Leuven and Gynaecologist (Dr. Prof.)

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 3, 2029
• Study Completion (Estimated): September 3, 2029
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

BE (1)