Malignant Pleural MesotheliomaNCT02269878
Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma
An observational study of Malignant Pleural Mesothelioma, run by Ain Shams University at 1 site in Egypt.
Trial summary
To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with malignant pleural mesothelioma (MPM)
Who may be able to join
- Patients with histologically confirmed Malignant Pleural Mesothelioma
- Age of 18 years or more.
- first-line chemotherapy with platinum-Based agents
Who cannot join
- history of prior malignancy.
- pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens
To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)
Read the detailed description
This study tries to find a correlation between single nucleotide polymorphisms (SNP) found in promoter region of Fas Ligand gene (rs 763110) and Fas (rs1800682) and clinical outcome on patients with MPM treated with platinum-Based agents as first line. the patients will have one of three following genotypes : Thymine/Thymine, Thymine/Cytosine or Cytosine/Cytosine (for Fas ligand polymorphism) and Adenine/Adenine, Adenine/Guanine or Guanine/Guanine ( for Fas polymorphism).
- Conditions
- Malignant Pleural Mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| people with MPM with Thymine/Thymine,Thymine/cytosine genotype | according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine. | |
| people with MPM, Cytosine/Cytosine genotype | according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Tumor response will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the modified Response Evaluation Criteria in Solid Tumors. Patients will be assigned to one of following groups: complete response (CR), Partial response (PR), Stable disease (SD) and progressive disease (PD).
Measured: After 6 cycles of chemotherapy (each cycle is 21 days )
Secondary outcomes (3)
progression free survival (PFS)
Progression-free survival (PFS) time is defined as the time from day 1 of chemotherapy to the day of documented disease progression or to death from any cause
Measured: one year
overall survival (OS)
time is defined as the time from day 1 of chemotherapy to death from any cause.
Measured: one year
estimation of treatment related toxicity
Hematologic (anemia, neutropenia, and thrombocytopenia) and non hematologic (nausea/vomiting, alopecia and nephrotoxicity) toxicities will be evaluated according to the National Cancer Institute-Common Toxicity Criteria. The worst degree of toxicity experienced throughout the treatment is used for the analysis. Toxicities of grade 2 or higher will be considered as clinically relevant.
Measured: during the chemotherapy period, average duration 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Abdo Mohammed Salem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269878
- Sponsor's protocol ID
- Master (No14)
- Status last verified
- Dec 2017
- First submitted
- 11 Oct 2014
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens
- ClinicalTrials.gov ID
- NCT02269878
- Acronym / sponsor ID
- Master (No14)
- Conditions
- Malignant Pleural Mesothelioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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.
To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)
Detailed description
This study tries to find a correlation between single nucleotide polymorphisms (SNP) found in promoter region of Fas Ligand gene (rs 763110) and Fas (rs1800682) and clinical outcome on patients with MPM treated with platinum-Based agents as first line. the patients will have one of three following genotypes : Thymine/Thymine, Thymine/Cytosine or Cytosine/Cytosine (for Fas ligand polymorphism) and Adenine/Adenine, Adenine/Guanine or Guanine/Guanine ( for Fas polymorphism).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| people with MPM with Thymine/Thymine,Thymine/cytosine genotype | – | –according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine. |
| people with MPM, Cytosine/Cytosine genotype | – | –according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with malignant pleural mesothelioma (MPM)
Key inclusion criteria (3 listed)
- Patients with histologically confirmed Malignant Pleural Mesothelioma
- Age of 18 years or more.
- first-line chemotherapy with platinum-Based agents
Key exclusion criteria (2 listed)
- history of prior malignancy.
- pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
response rate
Time frame: After 6 cycles of chemotherapy (each cycle is 21 days )
Tumor response will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the modified Response Evaluation Criteria in Solid Tumors. Patients will be assigned to one of following groups: complete response (CR), Partial response (PR), Stable disease (SD) and progressive disease (PD).
3 secondary outcomes
progression free survival (PFS)
Time frame: one year
overall survival (OS)
Time frame: one year
estimation of treatment related toxicity
Time frame: during the chemotherapy period, average duration 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Malignant Pleural Mesothelioma, run by Ain Shams University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 3 Jan 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: After 6 cycles of chemotherapy (each cycle is 21 days )). 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 3 Jan 2018.