An observational study in Trophoblastic Tumor, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Hospices Civils de Lyon · Observational
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.
7 studies on the registry are indexed under Trophoblastic Neoplasms; 2 are open to participants now.
Browse Trophoblastic Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
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Patients diagnosed with gestational trophoblastic tumors
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with gestational choriocarcinoma cured with methotrexate alone
Other: chemoresistance signature
patients with gestational choriocarcinoma not cured with methotrexate alone
Other: chemoresistance signature
patients with gestational choriocarcinoma cured with polychemotherapy
Other: chemoresistance signature
patients with gestational choriocarcinoma not cured with polychemotherapy
Other: chemoresistance signature
patients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls)
Other: chemoresistance signature
patients with placental site trophoblastic tumors not cured with polychemotherapy
Other: chemoresistance signature
to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
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.
Time frame: 10 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2018; primary completion for Oct 2018, 6 months later.
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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