CancerCSSINCT07461493
The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health Disparities in Cancer Care
An observational study of Cancer and Cancer Comorbidities, run by National Minority Quality Forum at 2 sites in United States.
Trial summary
The goal of this observational study is to establish a patient registry and a biorepository (sample collection and storage) to investigate health disparities, access, and barriers to cancer screening and early detection technologies. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer Comorbidities
- How many people
- 100,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2025to Mar 2039
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants ages 35 years and older from underserved communities, populations living near Superfund sites, designated cancer clusters, and areas affected by industrial contamination to be followed longitudinally over a decade to track cancer screenings and early detection of cancer. Sites will recruit and accrue patients from their clinic sites or at community outreach events community events, churches, health fairs, Federally Qualified Health Centers (FQHCs) and other venues.
Who may be able to join
- Adults 35 years and older.
- Participant provides written informed consent prior to initiation of any study procedures.
- Participant understands the purpose and procedures of the study.
- Participant agrees that demographic data, medical history, and social determinants of health on the enrollment questionnaires can be used for research purposes.
- Participant agrees to the release and review of their electronic medical record.
- Participant agrees to be followed for the duration outlined in this protocol.
Show all 11Show fewer
- Biorepository
- Participant is able, in the investigator's professional opinion, to provide up to 100 mLs of whole blood at the Screening Visit and at the Interim Visits.
- Participant is a healthy, nonpregnant adult.
- Participant weighs at least 110 pounds.
- Participant has negative viral test results.
Who cannot join
- Registry
- Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
- Participants who are unable to understand the study protocol or unable to give informed consent.
- Participants under the age of 35 at the time of enrollment.
- Biorepository
- Women of childbearing age that think they may be pregnant or are planning to get pregnant within the study timeframe.
- Participants who weigh under 110 pounds.
- Participants who, in the opinion of the investigator, are unable to provide biospecimen samples.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Life in 3D Health Services
Flint, Michigan, 48507
Denika Dalton, DNP-C, 810-780-4189, Denika@lifeinddd.com
Rockefeller Oteng, MD
- Recruiting
Grace Clinic
Houston, Texas, 77026
Sheila Young, FNP-BC, 713-993-6000, appt@graceclinichouston.com
Chi Si Choi, MD
About this study
The goal of this observational study is to establish a patient registry and a biorepository (sample collection and storage) to investigate health disparities, access, and barriers to cancer screening and early detection technologies. The registry and biorepository will serve as a resource to support Cancer Early Detection (CED) screenings and future research focused on communities at increased risk for cancer.
The study seeks to address:
Read more
•Barriers and disparities in cancer prevention, screening, and treatment, particularly in historically underrepresented populations.
Participants will:
- Attend a minimum of five clinic visits over a five-year period for scheduled annual assessments while actively enrolled in the study.
- Complete questionnaires at each visit that collect information on their medical history, cancer history, and family cancer history.
- Allow relevant health information from their electronic health records (EHR) to be collected and reviewed.
- Provide blood, saliva, and stool samples for research purposes.
- Enter a long-term follow-up period for an additional five years.
- Conditions
- Cancer, Cancer Comorbidities
- Keywords
- Early Detection, Cancer, Registry, Biorepository, Cancer cluster, CSSI, Cancer Stage Shifting Initiative, NMQF, National Minority Quality Forum, Health Disparities, Oncology, Cancer Screening, Tumor, superfund, environmental risks, SDOH
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Average Cancer Risk | Participants who are 35 years of age or older and have no identified cancer risk factors will be classified into the average-risk cohort. | |
| High Cancer Risk | Participants who are 35 years of age or older and have one or more cancer risk factors will be classified into the high-risk cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a patient registry
The primary objective of this study is to establish a patient registry that collects and characterizes health data from marginalized and underserved communities.
Measured: From enrollment to the end of follow up at 10 years.
Secondary outcomes (1)
Establish a biorepository
The secondary objective of this study is to establish a unique biorepository that collects and characterizes biological samples from marginalized and underserved communities. This biorepository will focus on cancer incidence, stage, type, and geography and enable exploratory research towards the development of novel early detection technologies.
Measured: From enrollment to the end of follow up at 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start11 Mar 2025
- Primary completionMar 2034 (estimated)
- Study completionMar 2039 (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
- 100,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- National Minority Quality Forum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461493
- Sponsor's protocol ID
- CSSI-ED-25
- Acronym
- CSSI
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision to share and what to share is pending. Ultimately, if decision to share in the future is confirmed to be 'Yes,' all opportunities will be evaluated in accordance with applicable regulations and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cancer Stage Shifting Initiative: Registry and Biorepository to Research and Address Health Disparities in Cancer Care
- ClinicalTrials.gov ID
- NCT07461493
- Acronym / sponsor ID
- CSSI / CSSI-ED-25
- Conditions
- Cancer, Cancer Comorbidities
- Keywords
- Early Detection, Cancer, Registry, Biorepository, Cancer cluster, CSSI, Cancer Stage Shifting Initiative, NMQF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- National Minority Quality ForumUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Mar 2039 (estimated)
- First posted
- 10 Mar 2026 (actual)
- 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 goal of this observational study is to establish a patient registry and a biorepository (sample collection and storage) to investigate health disparities, access, and barriers to cancer screening and early detection technologies. The registry and biorepository will serve as a resource to support Cancer Early Detection (CED) screenings and future research focused on communities at increased risk for cancer.
The study seeks to address:
•Barriers and disparities in cancer prevention, screening, and treatment, particularly in historically underrepresented populations.
Participants will:
- Attend a minimum of five clinic visits over a five-year period for scheduled annual assessments while actively enrolled in the study.
- Complete questionnaires at each visit that collect information on their medical history, cancer history, and family cancer history.
- Allow relevant health information from their electronic health records (EHR) to be collected and reviewed.
- Provide blood, saliva, and stool samples for research purposes.
- Enter a long-term follow-up period for an additional five years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Average Cancer Risk | – | –Participants who are 35 years of age or older and have no identified cancer risk factors will be classified into the average-risk cohort. |
| High Cancer Risk | – | –Participants who are 35 years of age or older and have one or more cancer risk factors will be classified into the high-risk cohort. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants ages 35 years and older from underserved communities, populations living near Superfund sites, designated cancer clusters, and areas affected by industrial contamination to be followed longitudinally over a decade to track cancer screenings and early detection of cancer. Sites will recruit and accrue patients from their clinic sites or at community outreach events community events, churches, health fairs, Federally Qualified Health Centers (FQHCs) and other venues.
Key inclusion criteria (11 listed)
- Adults 35 years and older.
- Participant provides written informed consent prior to initiation of any study procedures.
- Participant understands the purpose and procedures of the study.
- Participant agrees that demographic data, medical history, and social determinants of health on the enrollment questionnaires can be used for research purposes.
- Participant agrees to the release and review of their electronic medical record.
Key exclusion criteria (8 listed)
- Registry
- Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
- Participants who are unable to understand the study protocol or unable to give informed consent.
- Participants under the age of 35 at the time of enrollment.
- Biorepository
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
Establish a patient registry
Time frame: From enrollment to the end of follow up at 10 years.
The primary objective of this study is to establish a patient registry that collects and characterizes health data from marginalized and underserved communities.
1 secondary outcome
Establish a biorepository
Time frame: From enrollment to the end of follow up at 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided. Decision to share and what to share is pending. Ultimately, if decision to share in the future is confirmed to be 'Yes,' all opportunities will be evaluated in accordance with applicable regulations and ethical considerations.
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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.
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 and Cancer Comorbidities, run by National Minority Quality Forum at 2 sites 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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Establish a patient registry (time frame: From enrollment to the end of follow up at 10 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 8 Apr 2026.