Chemoresistance of Trophoblastic Tumors (PrediCTTro)

Civil Hospices of Lyon

Status: Unknown

Conditions: Trophoblastic Tumor

Treatments: Other: chemoresistance signature

Study type: Observational

Funder types: Other

Identifiers

NCT03488901

69HCL16_807

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• tissue specimen (block/biopsy) not available
• degraded quality of tissue sample not compatible with transcriptome analysis (>20% of necrosis)

Trial design

72 participants in 6 patient groups

methotrexate sensitive

Description:

patients with gestational choriocarcinoma cured with methotrexate alone

Treatment:

Other: chemoresistance signature

methotrexate resistant

Description:

patients with gestational choriocarcinoma not cured with methotrexate alone

Treatment:

Other: chemoresistance signature

polychemotherapy sensitive

Description:

patients with gestational choriocarcinoma cured with polychemotherapy

Treatment:

Other: chemoresistance signature

polychemotherapy resistant

Description:

patients with gestational choriocarcinoma not cured with polychemotherapy

Treatment:

Other: chemoresistance signature

hydatidiform moles without malignant transformation

Description:

patients treated for hydatidiform moles but who did not turn into trophoblastic tumors (=controls)

Treatment:

Other: chemoresistance signature

placental site trophoblastic tumors

Description:

patients with placental site trophoblastic tumors not cured with polychemotherapy

Treatment:

Other: chemoresistance signature