Ovarian TumorTORCHNCT02326064
Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI and Tumor Markers Such as CA125 and HE4
An observational study of Ovarian Tumor and Ovarian Cancer, run by Centre Hospitalier Departemental Vendee at 4 sites in France.
Trial summary
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Tumor, Ovarian Cancer
- How many people
- 221 participants
- Where
- 4 sitesFrance
- Study dates
- May 2015to Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patient hospitalized for surgery for presumed benign ovarian tumor
Who may be able to join
- patients to undergo surgery for an ovarian cyst
- presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group)
- agreement to participate in the study
Who cannot join
- pregnant patient
- minor patient
- Patient under guardianship, trusteeship, or deprived of liberty
- Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group.
- Patient with an adnexal torsion is suspected
- Patient unable to understand the proposed study
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier de Cholet
Cholet, 49300
CHD Vendée
La Roche-sur-Yon, 85925
CHU de Nantes
Nantes, 44093
CH de Saint Nazaire
Saint-Nazaire, 44606
About this study
Official title: Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor.
To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease.
The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.
- Conditions
- Ovarian Tumor, Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Marker CA125
CA125 < 35U/mL. Abnormal score if CA125 > 35U/mL.
Measured: Baseline
Tumor Marker HE4
HE4 < 70 pmol/L for premenopausal women or < 140 pmol/L for postmenopausal women
Abnormal score if HE4 > 70 pmol/L for premenopausal women or > 140 pmol/L for postmenopausal women
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian TumorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, PH, Study director, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326064
- Sponsor's protocol ID
- CHD064-14
- Acronym
- TORCH
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2014
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dochez V, Caillon H, Vaucel E, Dimet J, Winer N, Ducarme G. Biomarkers and algorithms for diagnosis of ovarian cancer: CA125, HE4, RMI and ROMA, a review. J Ovarian Res. 2019 Mar 27;12(1):28. doi: 10.1186/s13048-019-0503-7.
PubMed 30917847Dochez V, Randet M, Renaudeau C, Dimet J, Le Thuaut A, Winer N, Thubert T, Vaucel E, Caillon H, Ducarme G. Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial. J Clin Med. 2019 Oct 25;8(11):1784. doi: 10.3390/jcm8111784.
PubMed 31699959
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)
- ClinicalTrials.gov ID
- NCT02326064
- Acronym / sponsor ID
- TORCH / CHD064-14
- Conditions
- Ovarian Tumor, Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor.
To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease.
The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.
Study design
- Observational model
- Cohort
- 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
- Patient hospitalized for surgery for presumed benign ovarian tumor
Key inclusion criteria (3 listed)
- patients to undergo surgery for an ovarian cyst
- presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group)
- agreement to participate in the study
Key exclusion criteria (6 listed)
- pregnant patient
- minor patient
- Patient under guardianship, trusteeship, or deprived of liberty
- Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group.
- Patient with an adnexal torsion is suspected
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
Tumor Marker CA125
Time frame: Baseline
CA125 < 35U/mL. Abnormal score if CA125 > 35U/mL.
Tumor Marker HE4
Time frame: Baseline
HE4 < 70 pmol/L for premenopausal women or < 140 pmol/L for postmenopausal women Abnormal score if HE4 > 70 pmol/L for premenopausal women or > 140 pmol/L for postmenopausal women
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30917847Dochez V, Caillon H, Vaucel E, Dimet J, Winer N, Ducarme G. Biomarkers and algorithms for diagnosis of ovarian cancer: CA125, HE4, RMI and ROMA, a review. J Ovarian Res. 2019 Mar 27;12(1):28. doi: 10.1186/s13048-019-0503-7.
- Results publication: PubMed 31699959Dochez V, Randet M, Renaudeau C, Dimet J, Le Thuaut A, Winer N, Thubert T, Vaucel E, Caillon H, Ducarme G. Efficacy of HE4, CA125, Risk of Malignancy Index and Risk of Ovarian Malignancy Index to Detect Ovarian Cancer in Women with Presumed Benign Ovarian Tumours: A Prospective, Multicentre Trial. J Clin Med. 2019 Oct 25;8(11):1784. doi: 10.3390/jcm8111784.
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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.
Guillaume DUCARME, PH study director
CHD Vendée
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Tumor and Ovarian Cancer, run by Centre Hospitalier Departemental Vendee at 4 sites in France.
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 3 inclusion and 6 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tumor Marker CA125 (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326064, which also lists 2 linked publications.
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 2 Dec 2025.