Use of New MolEcular MarkErs for a persoNalized Therapy in Ovarian Cancer-MEMENTO

NCT06917469 | Completed

• 1 other identifier: CRO-2018-38
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian cancer (OC) is the leading cause of death from gynecologic cancer. It is estimated that 22,440 new cases of EOC will be diagnosed in 2017 with an estimated 14,080 EOC deaths. Several different histological subtypes of OC can be identified. Over 90% of malignant ovarian tumors are epithelial cancers (EOC), which are then classified into 5 broad histological subtypes: serous, endometrioid, mucinous, clear cell and mixed or carcinosarcomatous mullerian tumors. Almost 10 years ago, a new classification was proposed that separated ovarian cancers into type I and II tumors. Type II tumors included high-grade serous, which frequently contain mutations in p53, NF1, BRCA1, and BRCA2 and CDK125. Serous carcinomas represent the vast majority of primary malignant ovarian tumors (75%-80%), among these high-grade serous (HGSOC) accounts for 85%-90% and for the majority of the deaths due to ovarian cancer. The 5-year survival rate for EOC is only 46% because \>60% of patients are diagnosed with advanced disease. Patients with advanced stage EOC are typically managed with cytoreductive surgery and perioperative platinum-based chemotherapy, either in the adjuvant setting or with neoadjuvant chemotherapy and interval debulking surgery. Although primary advanced stage EOC is initially sensitive to this treatment paradigm, \>75% will eventually recur. Patients with recurrent disease are treated with additional lines of chemotherapy that may increase survival but is ultimately not curative. Given the high relapse rate and poor prognosis of advanced stage EOC, interest is increasing in the development of new approaches to treat recurrent EOC.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• To assess DNA-PK as a potential predictive biomarker for distinguishing patients who will benefit from CBDCA/TAX therapy from those who will respond more favorably to the CBDCA/PLD regimen, based on DNA-PK expression levels.

  Two years progression free survival will be estimated with Kaplan-Meier methods and reported as survival probability in the two treatment groups. PFS will be defined as time from the beginning of second line platinum based therapy and progression or death or end of follow-up whichever comes first

  up to 5 years

Secondary Outcomes (4)

• Evaluation of the Response Rate

  up to 5 years

• Evaluation of Overall Survival in the different treatment regimens

  Up to 5 years

• PFS in patients treated with biomarker driven therapy and physician's choice therapy

  up to 5 years

• OS in patients treated with biomarker driven therapy and physician's choice therapy

  up to 5 years

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

Subjects with histological diagnosis of high-grade ovarian carcinoma

You may qualify if:

• Age ≥ 18 years
• Diagnosis of a first relapse of high-grade ovarian cancer (≥12 months after the last platinum administration);
• p53 positive tumors evaluated by IHC (\>30% of stained tumor cells);
• Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 2;- Availability of the tumor sample for immunohistochemical analysis;
• Written informed consent.

You may not qualify if:

• Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin;
• Low p53 expression levels (\<30% of stained tumor cells);
• Persistent grade≥ 2 neuropathy;
• Severe heart disease;
• Surgeon's decision of a second curative surgery;
• Uncontrolled active infections;
• Insufficient patient compliance;
• Absence of signed informed consent

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico - IRCCS

Aviano, Italy

Location

MeSH Terms

Conditions

Ovarian 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: June 20, 2018
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

IT (1)