Clinical trial · Observational
Impact of O6-methylguanine-DNA Methyltransferase (MGMT) Promoter Methylation and MGMT Expression on Dacarbazine Treated Sarcoma Patients (MGMT)
NCT04893356CI-TRIAL-00070893MGMTunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MGMT study is a retrospective, non-profit, multi-center, observational study. The scientific objective of this study is to investigate whether MGMT expression or MGMT promoter methylation may represent a predictive marker for dacarbazine sensitivity in sarcoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation and MGMT expression on dacarbazine treated sarcoma patients | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Dacarbazine treated sarcoma patients
- description
- Approximately 75 patients with histological diagnosis of Leiomyosarcoma (SCL) and Solitary Fibrous Tumor(SFT), previously treated with dacarbazine alone or associated with anthracyclines, will be enrolled, diagnosed from 2010 to 2020. From formalin fixed tumor samples, DNA will be extracted and MGMT expression and MGMT promoter methylation analyzed.
- interventionNames
- Genetic: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation and MGMT expression on dacarbazine treated sarcoma patients
Primary outcomes (2)
- measure
- To analyze the expression of the MGMT gene in patients with Leiomyosarcoma (AML) and with metastatic Solitary Fibrous Tumor (SFT)
- timeFrame
- 1 year
- measure
- To analyze the methylation status of the MGMT promoter in histological specimens
- timeFrame
- 1 year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: \- Patients with a histological diagnosis of metastatic LMS and SFT from 2010 to 2020, previously treated with dacarbazine alone or with anthracyclines as first line of chemotherapy. Exclusion Criteria: * Patients with histological diagnosis of metastatic LMS and SFT, received before 2010. * Patients with histological diagnosis of metastatic LMS and SFT from 2010 to 2020, never treated with dacarbazine * Patients with a histological diagnosis of metastatic LMS and SFT from 2010 to 2020, previously treated with dacarbazine alone or with anthracyclines as the first line of chemotherapy, of which, however, there is no tissue sample
References
Publications (0)
Data not yet available
No reference posted for this study.