Metastatic Ovarian CancerMeta-FourNCT01768156
Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer
A study testing Experimental arm in people with Metastatic Ovarian Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial summary
HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Ovarian Cancer
- What is being tested?
- Experimental arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Sep 2010to 15 Nov 2016
- Phase
- Interventional
- 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
Who may be able to join
- Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
- Recurrence of anytime necessitating a new line of chemotherapy
- Patient having received adjuvant chemotherapy
- Informed consent signed prior any study specific procedures
Who cannot join
- More than 3 lines of chemotherapy
- Pregnancy or breastfeeding
- History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
- Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Bergonié
Bordeaux, 33076
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, 34298
About this study
Official title: Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.
- Conditions
- Metastatic Ovarian Cancer
- Being tested
- Experimental arm
- Keywords
- ovarian cancer, biomarker, metastatic
- Medical subject headings
- Ovarian Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armOther
Serum samples are collected:
- at time of diagnosis of recurrence (before 1st chemotherapy)
- during each cycle of chemotherapy
- after the end of chemotherapy
- every 3 month until treatment failure (3-6 samples)
- stop at the progression or after 18 months post chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Not described Receives: Other: Experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the predictive and prognostic value of HE4 marker
Measured: 18 months
Secondary outcomes (1)
Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study start24 Sep 2010
- Primary completion22 Sep 2015
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768156
- Sponsor's protocol ID
- Meta-Four
- Other IDs
- 2010-A00152-37
- Acronym
- Meta-Four
- Status last verified
- Oct 2020
- First submitted
- 9 Jan 2013
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
- ClinicalTrials.gov ID
- NCT01768156
- Acronym / sponsor ID
- Meta-Four / Meta-Four
- Conditions
- Metastatic Ovarian Cancer
- Keywords
- ovarian cancer, biomarker, metastatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 24 Sep 2010 (actual)
- Primary completion
- 22 Sep 2015 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 15 Jan 2013 (estimated)
- 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.
HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Other: Experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
- Recurrence of anytime necessitating a new line of chemotherapy
- Patient having received adjuvant chemotherapy
- Informed consent signed prior any study specific procedures
Key exclusion criteria (4 listed)
- More than 3 lines of chemotherapy
- Pregnancy or breastfeeding
- History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
- Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental armSerum samples are collected: * at time of diagnosis of recurrence (before 1st chemotherapy) * during each cycle of chemotherapy * after the end of chemotherapy * every 3 month until treatment failure (3-6 samples) * stop at the progression or after 18 months post chemotherapy | Other | Study arm |
Primary outcome
To evaluate the predictive and prognostic value of HE4 marker
Time frame: 18 months
1 secondary outcome
Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.
Time frame: 18 months
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 20 Oct 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental arm in people with Metastatic Ovarian Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 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 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: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 evaluate the predictive and prognostic value of HE4 marker (time frame: 18 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 20 Oct 2020.