NeoplasmNCT02875327
Linkage of Medicaid Enrollment Information to Surveillance, Epidemiology and End Results Data
An observational study of Neoplasm and Health Services Accessibility, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 120 years
- Conditions the study is for
- Neoplasm, Health Services Accessibility, Outcome Assessment
- How many people
- 3,217,145 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2016to 20 May 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 1 year to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medicaid beneficiaries diagnosed with cancer living in the SEER cancer registry catchment areas.
Who may be able to join
- Cancer Diagnosis
- Medicaid Member
- Registered within the SEER Program
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Linkage of Medicaid Enrollment Lnformation to Surveillance, Epidemiology and End Results Data
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.
Read more
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
Read the detailed 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.
- Keywords
- SEER, Medicaid, Cancer, Health Services Research, Epidemiology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start5 Aug 2016
- Primary completion20 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,217,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lindsey R Enewold, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875327
- Sponsor's protocol ID
- 999916163
- Other IDs
- 16-C-N163
- Status last verified
- May 2020
- First submitted
- 18 Aug 2016
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
Publications
Huang J, Shi H, Ge L, Zhu B, Liu J, Wang X, Han Z, Li Q, Wang Z. Epidemiologic and survival analysis of malignant peripheral nerve sheath tumors: a retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):8210-8214. doi: 10.1097/JS9.0000000000001756. No abstract available.
PubMed 38935102
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linkage of Medicaid Enrollment Lnformation to Surveillance, Epidemiology and End Results Data
- ClinicalTrials.gov ID
- NCT02875327
- Acronym / sponsor ID
- 999916163
- Keywords
- SEER, Medicaid, Cancer, Health Services Research, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,217,145 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 23 Aug 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.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medicaid beneficiaries diagnosed with cancer living in the SEER cancer registry catchment areas.
Key inclusion criteria (3 listed)
- Cancer Diagnosis
- Medicaid Member
- Registered within the SEER Program
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.
Primary outcome
Link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: PubMed 38935102Huang J, Shi H, Ge L, Zhu B, Liu J, Wang X, Han Z, Li Q, Wang Z. Epidemiologic and survival analysis of malignant peripheral nerve sheath tumors: a retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):8210-8214. doi: 10.1097/JS9.0000000000001756. No abstract available.
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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.
Lindsey R Enewold, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Neoplasm and Health Services Accessibility, run by National Cancer Institute (NCI) at 1 site in United States.
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 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: finished, as of the sponsor's last update on 21 May 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875327, which also lists 1 linked publication.
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 21 May 2020.