Ovarian CarcinomaPRONOV4IRNCT02595281
HE4 as a Relapse Biomarker in Ovarian Cancers
A study testing Experimental arm in people with Ovarian Carcinoma, run by Institut de Cancérologie de Lorraine at 7 sites in France.
Trial summary
HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Experimental arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Apr 2016to 18 Jul 2022
- 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
- Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
- Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
- Age ≥ 18 years .
- Performance status ECOG > or = 2
- Adequate haemoglobin rate ≥ 10 g/dL
- Ability to provide written informed consent
- Patient's legal capacity to consent to study participation
Who cannot join
- Any previous treatment with platinum for ovarian carcinoma
- Patient with visceral metastases
- Contraindication for blood test
- Contraindication for surgery
- Contraindication for bevacizumab treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
KALBACHER Elsa
Besançon, Hôpital Jean Minjoz, 25 030
BENGRINE-LEVEVRE Leïla
Dijon, Centre Georges François Leclerc, 21 079
LONGO Raphaelle
Metz, CHU Metz Thionville, 57085
SAVOYE Aude-Marie
Reims, Institut Jean Godinot, 51 056
DEMARCHI Martin
Strasbourg, Centre Paul Strauss, 67065
KURTZ Jean-Emmanuel
Strasbourg, Hôpital Civil, 67 091
GAVOILLE Céline
Vandœuvre-lès-Nancy, Institut de Cancérologie de Lorraine, 54 519
About this study
Official title: Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.
HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.
- Conditions
- Ovarian Carcinoma
- Being tested
- Experimental arm
- Keywords
- Ovarian Carcinoma, neoadjuvant, ROMA, Ca125, HE4, biomarker
- Medical subject headings
- Ovarian Neoplasms
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 each neoadjuvant chemotherapy cycle
- before surgery
- at each adjuvant chemotherapy cycle
- at each injection of bevacizumab as maintenance therapy
- stop at the progression or after 24 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
Serum concentration of HE4 (pMol) will be analysed at each visit
Measured: 24 months
Secondary outcomes (3)
Compare the evolution of HE4 and CA-125 serum concentration
Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle
Measured: 24 months
Evaluate the progression-free survival at 18 months
HE4 and CA125 will be compared with the rate of progression-free survival
Measured: 24 months
Evaluate the quality of surgery
HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start1 Apr 2016
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Gavoille, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595281
- Sponsor's protocol ID
- 2014-A01511-46
- Acronym
- PRONOV4IR
- Status last verified
- Dec 2022
- First submitted
- 2 Nov 2015
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.
- ClinicalTrials.gov ID
- NCT02595281
- Acronym / sponsor ID
- PRONOV4IR / 2014-A01511-46
- Conditions
- Ovarian Carcinoma
- Keywords
- Ovarian Carcinoma, neoadjuvant, ROMA, Ca125, HE4, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 3 Nov 2015 (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 more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.
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 (7 listed)
- Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
- Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
- Age ≥ 18 years .
- Performance status ECOG > or = 2
- Adequate haemoglobin rate ≥ 10 g/dL
Key exclusion criteria (5 listed)
- Any previous treatment with platinum for ovarian carcinoma
- Patient with visceral metastases
- Contraindication for blood test
- Contraindication for surgery
- Contraindication for bevacizumab treatment
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 each neoadjuvant chemotherapy cycle * before surgery * at each adjuvant chemotherapy cycle * at each injection of bevacizumab as maintenance therapy * stop at the progression or after 24 months post chemotherapy | Other | Study arm |
Primary outcome
To evaluate the predictive and prognostic value of HE4 marker
Time frame: 24 months
Serum concentration of HE4 (pMol) will be analysed at each visit
3 secondary outcomes
Compare the evolution of HE4 and CA-125 serum concentration
Time frame: 24 months
Evaluate the progression-free survival at 18 months
Time frame: 24 months
Evaluate the quality of surgery
Time frame: 24 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 19 Dec 2022.
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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.
Céline Gavoille, MD principal investigator
Institut de Cancérologie de Lorraine
7 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 Ovarian Carcinoma, run by Institut de Cancérologie de Lorraine at 7 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 7 inclusion and 5 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 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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: 24 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 19 Dec 2022.