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Clinical Trials in Italy / NCT06972693
Active, not recruiting Phase 4

NGS-based Germline and Somatic Genetic Test in Ovarian Carcinoma

NCT06972693 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Phase 4
Started
2018-06-12
Last updated
2025-05-15

Condition(s) studied

Ovarian CarcinomaFallopian Tube CarcinomaPrimary Peritoneal Carcinoma

Investigational drug(s) / intervention(s)

BRCA testing

BRCA testing: BRCA 1 and 2 testing

Study summary

For patients with ovarian cancer and biologically related diseases, the implementation of genetic testing in the decision-making process could have an impact both on the risk management for the patient and his/her family, but also, more importantly, on the therapeutic management.

The identification of genetically predisposed subjects can suggest risk reduction strategies that may involve bilateral salpingo-oophorectomy, mastectomy or long-term medical approaches. In the advanced setting, genetic testing may influence the decision for medical therapy (e.g. use of platinum derivatives or PARP inhibitors in patients with "BRCAness+" ovarian cancer).

The selection of patients for genetic testing has so far been restricted to patients with a strong family history of breast and ovarian cancer. It is now clear that the strict application of this criterion will result in a substantial number of people with a missed BRCA mutation.

Systematic large-scale genetic testing, simultaneously on germline and somatic tissues, is likely to improve decision-making algorithms in ovarian cancer patients. The feasibility of such an approach in the clinical setting, in terms of response times compatible with clinical needs and sensitivity comparable if not superior to single-gene tests, needs to be demonstrated before such diagnostic platforms can be routinely implemented in the diagnostic workflow.

This is the aim of the present study.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. age 18 or higher 2. has signed informed consent 3. histologically confirmed ovarian cancer, Fallopian tube cancer, or primary peritoneal cancer. 4. Any stage is admitted 5. Any histology is admitted 6. availability of surgical/bioptic material. Formalin-fixed, paraffinembedded or frozen specimens are both allowed, with no time limitation Exclusion Criteria: 1\. unable or unwilling to receive genetic counseling

Primary outcome measure(s)

  • Prevalence of clinically relevant mutations in ovarian cancer riskassociated genes — 3 months
    evaluate prevalence of clinically relevant mutations in ovarian cancer risk associated genes
  • Percentage of informative specimens — 3 months
    Percentage of informative specimens
  • Genetic test turnaround time — 3 months
    Evaluate Genetic test turnaround time

Trial sites (1)

FacilityCityRegionStatus
Istituto Europeo di Oncologia Milan Italy

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YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. Recruiting
A New Tool to Promote Patient's Engagement in Their Healthcare Process Recruiting
Cognitive Impairment Assessment in Breast Cancer Survivors Starting soon
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site Recruiting

Other trials for the same condition

A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy Recruiting
Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy Recruiting
First in Human Study of IMGN151 in Recurrent Gynaecological Cancers Active, not recruiting
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases. Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06972693 on ClinicalTrials.gov ↗ ← All trials in Italy