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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02875327
Other study ID # 999916163
Secondary ID 16-C-N163
Status Completed
Phase
First received
Last updated
Start date August 5, 2016
Est. completion date May 20, 2020

Study information

Verified date May 2020
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

The SEER database collects data about people with cancer. SEER stands for Surveillance, Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who have low income or serious medical needs. Many studies have shown that Medicaid recipients with cancer are more likely to be diagnosed later in the disease than people with other insurance. They are also less likely to get treatment. Researchers want to compare Medicaid data and SEER data. They want to make this available to other scientists.

Objectives:

To link people in the SEER database to Medicaid data for the years around their cancer diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers.

Eligibility:

No people are enrolled in this study.

Design:

The SEER finder file will be securely uploaded to the CMS Data Center.

The finder file will be matched against the Medicaid Personal Summary file at the CMS Data Center.

If participants appear in both the SEER file and Medicaid file, their data will be extracted.

The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers will see if the Medicaid dates fall in certain periods. These are 12 months before, the month of, and 11 months after diagnosis.

If participants are eligible for Medicaid for these periods, a flag will be created in the file. It will note the participants is eligible and why.

The SEER finder file will be destroyed.

The only data saved will be:

Each participant's unique random SEER case number linked to their Medicaid number

Monthly flags about Medicaid eligibility


Description:

Numerous studies have demonstrated that Medicaid recipients with cancer are more likely to be diagnosed at an advance stage and less likely to receive recommended treatment than are patients with other types of health insurance. The objective of this project is to link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information during the year before and after their cancer diagnosis. NCI is also seeking permission to create and maintain a file that crosswalks each patient's SEER case number to their Medicaid enrollment number. Information about Medicaid enrollment would be available by special request to all researchers who want to use SEER data to assess the impact of Medicaid enrollment on stage and treatment.


Recruitment information / eligibility

Status Completed
Enrollment 3217145
Est. completion date May 20, 2020
Est. primary completion date May 20, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 120 Years
Eligibility - INCLUSION:

- Cancer Diagnosis

- Medicaid Member

- Registered within the SEER Program

EXCLUSION:

-None

Study Design


Locations

Country Name City State
United States National Cancer Institute (NCI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information 7 years
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