Cancer - OvarianFORCENCT07407062
A Study to Evaluate Folate Receptor Alpha (FRα) Expression in Adult Participants With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Italy
An observational study of Cancer - Ovarian, run by AbbVie at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the prevalence of folate receptor alpha (FRα)-positive status (≥75% viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) in participants with high-grade serous ovarian, fallopian tube, and primary peritoneal cancer, stratified by time of sampling (initial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer - Ovarian
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jun 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will be performed on archived tissue samples from approximately 200 eligible female adult participants with relapsed high grade serous epithelial ovarian cancer.
Who may be able to join
- Relapsed ovarian, fallopian tube and primary peritoneal cancer
- Histologically high-grade serous carcinoma
- Presence of archived surgical tissue samples from participants with epithelial ovarian cancer at diagnosis and at 1st recurrence in the same participants
- Available samples collected from January 1st, 2016 to study start date (defined as study site initiation visit date) that are considered adequate for the Ventana folate receptor alpha (FOLR1) RxDx assay by the site pathologist
Who cannot join
- Histological ambiguous diagnosis upon review
- Diagnosis based on cytology and without any biopsy or surgical specimen
- Other histotypes than high grade serous ovarian cancer, fallopian tube cancer and primary peritoneal cancer
- Archival or recurrent sample for the same participant not available
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 280205
Rome, Roma, 00168
About this study
Official title: Folate Receptor Alpha Expression in Relapsed Ovarian, Fallopian Tube and Primary Peritoneal Cancer: a Realworld prEvalence Study in Italy
The purpose of this study is to evaluate the prevalence of folate receptor alpha (FRα)-positive status (≥75% viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) in participants with high-grade serous ovarian, fallopian tube, and primary peritoneal cancer, stratified by time of sampling (initial diagnosis versus relapse), adhering to Ventana folate receptor alpha (FOLR1) RxDx (prescription diagnosis) assay Interpretation Guidance.
- Conditions
- Cancer - Ovarian
- Keywords
- Cancer - Ovarian
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Folate Receptor Alpha (FRα) | Samples of eligible participants with ovarian cancer will be analyzed retrospectively for folate receptor alpha (FRα) expression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FRα - Positive Status
FRα - positive status, defined as ≥75% viable tumor cells demonstrating moderate (2+) and/or strong (3+) membrane staining with the Ventana FOLR1 RxDx assay, at diagnosis and/or at relapse.
Measured: Up to Approximately 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start26 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer - OvarianStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407062
- Sponsor's protocol ID
- H26-138
- Acronym
- FORCE
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folate Receptor Alpha Expression in Relapsed Ovarian, Fallopian Tube and Primary Peritoneal Cancer: a Realworld prEvalence Study in Italy
- ClinicalTrials.gov ID
- NCT07407062
- Acronym / sponsor ID
- FORCE / H26-138
- Conditions
- Cancer - Ovarian
- Keywords
- Cancer - Ovarian
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Feb 2026 (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.
The purpose of this study is to evaluate the prevalence of folate receptor alpha (FRα)-positive status (≥75% viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) in participants with high-grade serous ovarian, fallopian tube, and primary peritoneal cancer, stratified by time of sampling (initial diagnosis versus relapse), adhering to Ventana folate receptor alpha (FOLR1) RxDx (prescription diagnosis) assay Interpretation Guidance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Folate Receptor Alpha (FRα) | – | –Samples of eligible participants with ovarian cancer will be analyzed retrospectively for folate receptor alpha (FRα) expression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be performed on archived tissue samples from approximately 200 eligible female adult participants with relapsed high grade serous epithelial ovarian cancer.
Key inclusion criteria (4 listed)
- Relapsed ovarian, fallopian tube and primary peritoneal cancer
- Histologically high-grade serous carcinoma
- Presence of archived surgical tissue samples from participants with epithelial ovarian cancer at diagnosis and at 1st recurrence in the same participants
- Available samples collected from January 1st, 2016 to study start date (defined as study site initiation visit date) that are considered adequate for the Ventana folate receptor alpha (FOLR1) RxDx assay by the site pathologist
Key exclusion criteria (4 listed)
- Histological ambiguous diagnosis upon review
- Diagnosis based on cytology and without any biopsy or surgical specimen
- Other histotypes than high grade serous ovarian cancer, fallopian tube cancer and primary peritoneal cancer
- Archival or recurrent sample for the same participant not available
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
FRα - Positive Status
Time frame: Up to Approximately 6 Months
FRα - positive status, defined as ≥75% viable tumor cells demonstrating moderate (2+) and/or strong (3+) membrane staining with the Ventana FOLR1 RxDx assay, at diagnosis and/or at relapse.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
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 Cancer - Ovarian, run by AbbVie 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caterina Golotta (+39 06 548891, caterina.golotta@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FRα - Positive Status (time frame: Up to Approximately 6 Months). 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 27 Jul 2026.