Trophoblastic TumorPrediCTTroNCT03488901
Chemoresistance of Trophoblastic Tumors
An observational study of Trophoblastic Tumor, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Trophoblastic Tumor
- What is being tested?
- chemoresistance signature
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2018to Dec 2018
- 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 to 60 years
- Women only
- Adult
Study population: Patients diagnosed with gestational trophoblastic tumors
Who may be able to join
- confirmed gestational trophoblastic tumor histology
- hCG follow-up of at least 12 months after hCG normalization
- registration in the French Reference Center for Trophoblastic Diseases
Who cannot join
- tissue specimen (block/biopsy) not available
- degraded quality of tissue sample not compatible with transcriptome analysis (>20% of necrosis)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Français de Référence des Maladies Trophoblastiques
Pierre-Bénite, 69495
Pierre-Adrien BOLZE, Dr, 04 78 86 56 40 ext. +33, pierre-adrien.bolze@chu-lyon.fr
François GOLFIER, Pr, 04 78 86 66 78 ext. +33, francois.golfier@chu-lyon.fr
About this study
Official title: Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors
Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.
The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .
Read more
To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.
The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.
The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.
- Conditions
- Trophoblastic Tumor
- Being tested
- chemoresistance signature
- Medical subject headings
- Trophoblastic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoresistance signatureOther
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| methotrexate sensitive | patients with gestational choriocarcinoma cured with methotrexate alone Receives: Other: chemoresistance signature | |
| methotrexate resistant | patients with gestational choriocarcinoma not cured with methotrexate alone Receives: Other: chemoresistance signature | |
| polychemotherapy sensitive | patients with gestational choriocarcinoma cured with polychemotherapy Receives: Other: chemoresistance signature | |
| polychemotherapy resistant | patients with gestational choriocarcinoma not cured with polychemotherapy Receives: Other: chemoresistance signature | |
| hydatidiform moles without malignant transformation | patients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls) Receives: Other: chemoresistance signature | |
| placental site trophoblastic tumors | patients with placental site trophoblastic tumors not cured with polychemotherapy Receives: Other: chemoresistance signature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcription profile associated with the resistance to chemotherapy
The expression level of 800 genes involved in oncogenesis canonical pathways and immune tolerance will be assessed and correlated with the resistance to single or multiagent chemotherapy.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trophoblastic TumorStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488901
- Sponsor's protocol ID
- 69HCL16_807
- Acronym
- PrediCTTro
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors
- ClinicalTrials.gov ID
- NCT03488901
- Acronym / sponsor ID
- PrediCTTro / 69HCL16_807
- Conditions
- Trophoblastic Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Apr 2018 (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.
Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.
The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .
To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.
The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.
The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| methotrexate sensitive | – | Other: chemoresistance signaturepatients with gestational choriocarcinoma cured with methotrexate alone |
| methotrexate resistant | – | Other: chemoresistance signaturepatients with gestational choriocarcinoma not cured with methotrexate alone |
| polychemotherapy sensitive | – | Other: chemoresistance signaturepatients with gestational choriocarcinoma cured with polychemotherapy |
| polychemotherapy resistant | – | Other: chemoresistance signaturepatients with gestational choriocarcinoma not cured with polychemotherapy |
| hydatidiform moles without malignant transformation | – | Other: chemoresistance signaturepatients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls) |
| placental site trophoblastic tumors | – | Other: chemoresistance signaturepatients with placental site trophoblastic tumors not cured with polychemotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients diagnosed with gestational trophoblastic tumors
Key inclusion criteria (3 listed)
- confirmed gestational trophoblastic tumor histology
- hCG follow-up of at least 12 months after hCG normalization
- registration in the French Reference Center for Trophoblastic Diseases
Key exclusion criteria (2 listed)
- tissue specimen (block/biopsy) not available
- degraded quality of tissue sample not compatible with transcriptome analysis (>20% of necrosis)
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 |
|---|---|---|
| chemoresistance signatureto study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy | Other | hydatidiform moles without malignant transformation, methotrexate resistant, methotrexate sensitive, placental site trophoblastic tumors, polychemotherapy resistant, polychemotherapy sensitive |
Primary outcome
Transcription profile associated with the resistance to chemotherapy
Time frame: 10 months
The expression level of 800 genes involved in oncogenesis canonical pathways and immune tolerance will be assessed and correlated with the resistance to single or multiagent chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
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 Trophoblastic Tumor, run by Hospices Civils de Lyon at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Adrien BOLZE, Dr (04 78 86 56 40 ext. +33, pierre-adrien.bolze@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcription profile associated with the resistance to chemotherapy (time frame: 10 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 5 Apr 2018.