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Status unknownNCT02783885Updated May 26, 2016

Clinical Utilization of Newly Approved Oncology Medications

An observational study in Cancer, sponsored by National Guard Health Affairs. Status unknown at 2 sites in Saudi Arabia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-26.

Sponsored by National Guard Health Affairs · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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

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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.

02

Conditions studied

  • Cancer

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03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 100 is below the median of 204 across 1,745 observational studies indexed under Neoplasms.

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Lead sponsor

National Guard Health Affairs is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Drugimmunotherapy
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What researchers measure

Primary outcomes

  1. Descriptive measures of the pattern of use of the new medications in our population

    Time frame: 3 years

Secondary outcomes

  1. Measuring the efficacy in terms of response

    Time frame: 3 years

  2. Measuring the efficacy in terms of progression-free survival (PFS)

    Time frame: 3 years

  3. Measuring the efficacy in terms of overall survival (OS)

    Time frame: 3 years

07

Study locations

2 of 2 sites recruiting
  • King Abdul Aziz Medical City for National Guard Health Affairs
    Riyadh, 11426, Saudi Arabia
    Recruiting
  • King Abdul Aziz Medical City for National Guard
    Riyadh, Saudi Arabia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02783885
Lead sponsor
National Guard Health Affairs
Responsible party
Sponsor
First posted
May 26, 2016
Start date
May 2016
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
May 26, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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