CancerNCT02783885
Clinical Utilization of Newly Approved Oncology Medications
An observational study of Cancer, run by National Guard Health Affairs at 2 sites in Saudi Arabia.
Trial summary
The efficacy and safety of different medications vary from one individual to another and from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and pharmacoepidemiology has evolved recently. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- immunotherapy
- How many people
- 100 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- May 2016to Sep 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Oncology centers managing patients with solid tumors or hematological malignancies in the national Guard and the investigators can open it in other Middle Eastern countries if the investigators need more sample size as Tawam Hospital (UAE), Alhamad Hospital (Qatar), AUB (Lebanon) and Algeria
Who may be able to join
- All patients with cancer or hematological malignancies receiving new oncology medications (defined as a medication in the first five years of their introduction to the ME market
- Patient accepts to participate in study and signing consent form
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, 11426
Abdularahman Jazieh, MD,MPH, 0096612520088 ext. 14688, jazieha@ngha.med.sa
Oncology Research, 0096612520088 ext. 14601, oncologyresearch@ngha.med.sa
- Recruiting
King Abdul Aziz Medical City for National Guard
Riyadh
Nagham RZ Sheblaq, 009668011111 ext. 53352, sheblaqn@ngha.med.sa
009668011111 ext. 53352, sheblaqn@ngha.med.sa
About this study
Official title: Clinical Utilization of Newly Approved Oncology Medications in Middle Eastern Population
The efficacy and safety of different medications vary from one individual to another and from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and pharmacoepidemiology has evolved recently.
There are multiple examples of oncology drugs being more effective in certain ethnic population compared to other. For example, irinotecan combined with cisplatin was very effective drug in the management of small cell lung cancer in the Japanese patients while an identical study done in the US revealed no major benefit to this combination in American population
Read the detailed description
Another example is having more benefit drawn from tyrosine kinase inhibitors (Erlotinib or Gefitinib) in Asian patients.
Immunotherapy is a new class of cancer treatment that works to harness the innate powers of the immune system to fight cancer. Because of the immune system's unique properties, these therapies may hold greater potential than current treatment approaches to fight cancer more powerfully, to offer longer-term protection against the disease, to come with fewer side effects, and to benefit more patients with more cancer types
Immunotherapy includes treatments that work in different ways. Some boost the body's immune system in a very general way. Others help train the immune system to attack cancer cells specifically. Immunotherapy has become an important part of treating some types of cancer. Newer types of immune treatments are now being studied, and they'll impact how we treat cancer in the future.
Recently, multiple immunotherapy treatment been approved with a couple of EGFR resistant medications.
Many new oncology drugs are being used in Middle Eastern countries including Saudi Arabia for different indications without being studied in the Middle Eastern population. These medications' efficacy and safety profiles may differ from those patients studied for drug development and approval due to difference in population's characteristics.
The goal of this study is to observe, summarize and report the patterns of the use of these drugs and describe their efficacy and safety profile in the early phases of their use.
The investigators aim is to build on the existing experience and knowledge by utilization of classic methodology and approaches on a larger scale and more effective way to paint picture of the performance of a certain therapy in the real life world. The use of prospective design will help evaluate the efficacy and safety of therapies already used in practice, generate new hypothesis, and/or determine the outcome of certain diseases.
- Conditions
- Cancer
- Being tested
- immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive measures of the pattern of use of the new medications in our population
Measured: 3 years
Secondary outcomes (3)
Measuring the efficacy in terms of response
Measured: 3 years
Measuring the efficacy in terms of progression-free survival (PFS)
Measured: 3 years
Measuring the efficacy in terms of overall survival (OS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Guard Health Affairs
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783885
- Sponsor's protocol ID
- RC15/097/R
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utilization of Newly Approved Oncology Medications in Middle Eastern Population
- ClinicalTrials.gov ID
- NCT02783885
- Acronym / sponsor ID
- RC15/097/R
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Guard Health AffairsOther government
- Study start
- May 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 26 May 2016 (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.
The efficacy and safety of different medications vary from one individual to another and from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and pharmacoepidemiology has evolved recently.
There are multiple examples of oncology drugs being more effective in certain ethnic population compared to other. For example, irinotecan combined with cisplatin was very effective drug in the management of small cell lung cancer in the Japanese patients while an identical study done in the US revealed no major benefit to this combination in American population
Detailed description
Another example is having more benefit drawn from tyrosine kinase inhibitors (Erlotinib or Gefitinib) in Asian patients.
Immunotherapy is a new class of cancer treatment that works to harness the innate powers of the immune system to fight cancer. Because of the immune system's unique properties, these therapies may hold greater potential than current treatment approaches to fight cancer more powerfully, to offer longer-term protection against the disease, to come with fewer side effects, and to benefit more patients with more cancer types
Immunotherapy includes treatments that work in different ways. Some boost the body's immune system in a very general way. Others help train the immune system to attack cancer cells specifically. Immunotherapy has become an important part of treating some types of cancer. Newer types of immune treatments are now being studied, and they'll impact how we treat cancer in the future.
Recently, multiple immunotherapy treatment been approved with a couple of EGFR resistant medications.
Many new oncology drugs are being used in Middle Eastern countries including Saudi Arabia for different indications without being studied in the Middle Eastern population. These medications' efficacy and safety profiles may differ from those patients studied for drug development and approval due to difference in population's characteristics.
The goal of this study is to observe, summarize and report the patterns of the use of these drugs and describe their efficacy and safety profile in the early phases of their use.
The investigators aim is to build on the existing experience and knowledge by utilization of classic methodology and approaches on a larger scale and more effective way to paint picture of the performance of a certain therapy in the real life world. The use of prospective design will help evaluate the efficacy and safety of therapies already used in practice, generate new hypothesis, and/or determine the outcome of certain diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology centers managing patients with solid tumors or hematological malignancies in the national Guard and the investigators can open it in other Middle Eastern countries if the investigators need more sample size as Tawam Hospital (UAE), Alhamad Hospital (Qatar), AUB (Lebanon) and Algeria
Key inclusion criteria (2 listed)
- All patients with cancer or hematological malignancies receiving new oncology medications (defined as a medication in the first five years of their introduction to the ME market
- Patient accepts to participate in study and signing consent form
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| immunotherapy | Drug | – |
Primary outcome
Descriptive measures of the pattern of use of the new medications in our population
Time frame: 3 years
3 secondary outcomes
Measuring the efficacy in terms of response
Time frame: 3 years
Measuring the efficacy in terms of progression-free survival (PFS)
Time frame: 3 years
Measuring the efficacy in terms of overall survival (OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Individual participant dataSharing planned: No
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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.
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, Saudi Arabia
King Abdul Aziz Medical City for National Guard
Riyadh, Saudi Arabia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by National Guard Health Affairs at 2 sites in Saudi Arabia.
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 2 inclusion and 1 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive measures of the pattern of use of the new medications in our population (time frame: 3 years). 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 26 May 2016.