NCT02783885

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

4.3 years

First QC Date

May 12, 2016

Last Update Submit

May 23, 2016

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Descriptive measures of the pattern of use of the new medications in our population

    3 years

Secondary Outcomes (3)

  • Measuring the efficacy in terms of response

    3 years

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

    3 years

  • Measuring the efficacy in terms of overall survival (OS)

    3 years

Interventions

immunotherapyDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

MeSH Terms

Conditions

Neoplasms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 26, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

May 26, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

SA(2)