Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of O6-methylguanine-DNA Methyltransferase (MGMT) Promoter Methylation and MGMT Expression on Dacarbazine Treated Sarcoma Patients (MGMT) (MGMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04893356
Recruitment Status : Active, not recruiting
First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief Summary:
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.

Condition or disease Intervention/treatment
Sarcoma Genetic: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation and MGMT expression on dacarbazine treated sarcoma patients

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of O6-methylguanine-DNA Methyltransferase (MGMT) Promoter Methylation and MGMT Expression on Dacarbazine Treated Sarcoma Patients (MGMT)
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Dacarbazine treated sarcoma patients

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.

Genetic: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation and MGMT expression on dacarbazine treated sarcoma patients

Tumor samples of Leiomyosarcoma and Solitary Fibrous Tumours patients, dacarbazine (as single agents or in combination with anthracyclines) treated, will be obtained from and characterized by the Pathology Unit of the "Istituto Nazionale Tumori Fondazione Pascale" in Naples, Campus Biomedico of Rome, Istituto Oncologico of Bari and University of Palermo.

Glioblastomas control samples will be obtained from CEINGE-Biotecnologie Avanzate, in Naples and characterized by the Pathology Unit of the University of Naples "Federico II".

After biopsy or surgical resection, the tissues were fixed in 10% formalin and included in paraffin blocks. All patients partecipating in this study provided informed consent.





Primary Outcome Measures :
  1. To analyze the expression of the MGMT gene in patients with Leiomyosarcoma (AML) and with metastatic Solitary Fibrous Tumor (SFT) [ Time Frame: 1 year ]
  2. To analyze the methylation status of the MGMT promoter in histological specimens [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To investigate whether MGMT activity or MGMT promoter methylation may also represent a predictive marker for dacarbazine sensitivity in sarcomas [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Human DNA will be extracted from tumor tissues using the FFPE DNA Tissue Kit (Qiagen, Hilden, Germany), following the manufacturer's instructions. DNA quality will be checked using NanoDrop 2000 (Thermo Scientific, Waltham, MA, USA). Genomic DNA (500ng) will be converted by sodium bisulfite with the EZ DNA Methylation Gold Kit (Zymo Research, Irvine, CA, USA) and eluted in 20μL RNase free water, according to the manufacturer's instructions.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tumor specimens from patients with Leiomyosarcoma (SCL) and Solitary Fibrous Tumors (SFT), treated with dacarbazine (as a single agent or in combination with anthracyclines), after biopsy or surgical resection, are fixed in 10% formalin and included in blocks of paraffin. They will be compared with control samples of glioblastomas (provided by the CEINGE-Biotechnologies Advanced, of Naples).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893356


Locations
Layout table for location information
Italy
National Cancer Institute of Naples
Naples, Campania, Italy, 80131
Sponsors and Collaborators
National Cancer Institute, Naples
Layout table for additonal information
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT04893356    
Other Study ID Numbers: MGMT
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents