Ovarian CancerMEMENTONCT06917469
Use of New MolEcular MarkErs for a persoNalized Therapy in Ovarian Cancer-MEMENTO
An observational study of Ovarian Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2018to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with histological diagnosis of high-grade ovarian carcinoma
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 5 years
Secondary outcomes (4)
Evaluation of the Response Rate
Response rate will be reported as numbers and percentages and evaluated based on RECIST 1.1 criteria
Measured: up to 5 years
Evaluation of Overall Survival in the different treatment regimens
Overall Survival (OS) will be evaluated with Kaplan-Meier methods and reported separately for the two treatment groups. OS will be defined as time from the beginning of second line platinum based therapy and death or end of follow-up whichever comes first
Measured: Up to 5 years
PFS in patients treated with biomarker driven therapy and physician's choice therapy
Difference in PFS between subgroups of patients will be evaluated with Kaplan-Meier method and log-rank test
Measured: up to 5 years
OS in patients treated with biomarker driven therapy and physician's choice therapy
Difference in OS between subgroups of patients will be evaluated with Kaplan-Meier method and log-rank test
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start20 Jun 2018
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917469
- Sponsor's protocol ID
- CRO-2018-38
- Acronym
- MEMENTO
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of New MolEcular MarkErs for a persoNalized Therapy in Ovarian Cancer-MEMENTO
- ClinicalTrials.gov ID
- NCT06917469
- Acronym / sponsor ID
- MEMENTO / CRO-2018-38
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with histological diagnosis of high-grade ovarian carcinoma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: up to 5 years
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
4 secondary outcomes
Evaluation of the Response Rate
Time frame: up to 5 years
Evaluation of Overall Survival in the different treatment regimens
Time frame: Up to 5 years
PFS in patients treated with biomarker driven therapy and physician's choice therapy
Time frame: up to 5 years
OS in patients treated with biomarker driven therapy and physician's choice therapy
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.