Non Small Cell Lung CancerNCT05746598
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients
An observational study of Non Small Cell Lung Cancer and Nephropathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Nephropathy, Cardiotoxicity
- What is being tested?
- Cisplatin injection
- Type of treatment
- Injection or infusion
- How many people
- 178 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Apr 2023
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: • NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
Who may be able to join
- NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
- Measurable disease.
- Age of 18 years to 80 years.
Who cannot join
- Non-small cell lung cancer patients who had undergone radiotherapy or chemotherapy.
- Pregnant and lactating females.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin.
- Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Mona Schaalan, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11315
Neven Sarhan, PhD, +201021944422, sarhanneven@gmail.com
About this study
Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient outcomes in terms of survival and safety profile. Current guidelines advocate for personalized treatment options based on molecular and immunologic characteristics, which drives the physician's decision toward tailored oncology.
In the last two to three decades, hundreds of cancer biological prognostic markers for non-small cell lung cancer have been proposed. Although they have shown a potential in this field, validation studies are still required and, to date, there is in sufficient evidence to recommend the routine clinical use of any of these putative biomarkers. Therefore, the discovery of robust prognostic and/or predictive biomarkers in patients with non-small cell lung cancer is imperative for advancing treatment strategies for the disease and improving patient care.
- Conditions
- Non Small Cell Lung Cancer, Nephropathy, Cardiotoxicity
- Being tested
- Cisplatin injection
- Keywords
- Non-small cell lung Cancer, Nephropathy, Cardiotoxicity, Gene polymorphism, Cisplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Kidney Diseases, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin injectionDrug
Cisplatin 75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 1 | NSCLC patients Who developed Toxicity to Chemotherapeutic agents Receives: Drug: Cisplatin injection | |
| 2 | NSCLC patients Who did not developToxicity to Chemotherapeutic agents Receives: Drug: Cisplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nephrotoxicity
Change in Creatinine Clearance
Measured: 6 months
Secondary outcomes (3)
Blood urea nitrogen
Change in Blood urea nitrogen
Measured: 6 months
Serum creatinine
change in Serum creatinine
Measured: 6 month
Cardiotoxicity
Change in ejection fraction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jul 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University
- Responsible party
- Principal investigator, Neven Sarhan, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746598
- Sponsor's protocol ID
- NSCLC-Genetics
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05746598
- Acronym / sponsor ID
- NSCLC-Genetics
- Conditions
- Non Small Cell Lung Cancer, Nephropathy, Cardiotoxicity
- Keywords
- Non-small cell lung Cancer, Nephropathy, Cardiotoxicity, Gene polymorphism, Cisplatin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr International University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- 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.
Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient outcomes in terms of survival and safety profile. Current guidelines advocate for personalized treatment options based on molecular and immunologic characteristics, which drives the physician's decision toward tailored oncology.
In the last two to three decades, hundreds of cancer biological prognostic markers for non-small cell lung cancer have been proposed. Although they have shown a potential in this field, validation studies are still required and, to date, there is in sufficient evidence to recommend the routine clinical use of any of these putative biomarkers. Therefore, the discovery of robust prognostic and/or predictive biomarkers in patients with non-small cell lung cancer is imperative for advancing treatment strategies for the disease and improving patient care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Cisplatin injectionNSCLC patients Who developed Toxicity to Chemotherapeutic agents |
| 2 | – | Drug: Cisplatin injectionNSCLC patients Who did not developToxicity to Chemotherapeutic agents |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
Key inclusion criteria (3 listed)
- NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
- Measurable disease.
- Age of 18 years to 80 years.
Key exclusion criteria (4 listed)
- Non-small cell lung cancer patients who had undergone radiotherapy or chemotherapy.
- Pregnant and lactating females.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin.
- Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin injectionCisplatin 75mg/m2 | Drug | 1, 2 |
Primary outcome
Nephrotoxicity
Time frame: 6 months
Change in Creatinine Clearance
3 secondary outcomes
Blood urea nitrogen
Time frame: 6 months
Serum creatinine
Time frame: 6 month
Cardiotoxicity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mona Schaalan, PhD contact
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 Non Small Cell Lung Cancer and Nephropathy, 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 4 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: status not confirmed, as of the sponsor's last update on 28 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neven Sarhan, PhD (+201021944422, sarhanneven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nephrotoxicity (time frame: 6 months). 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 28 Feb 2023.