- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06826014
TREC@TAMU Cancer Forebyggelsesregister og depot
Texas Regional Excellence in Cancer (TREC) @Texas A&M University Cancer Cancer Prevention Registry and Repository
This study collects health and genetic information to implement cancer prevention and treatment strategies.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This research will explore how genetics, diet, exercise, and jobs influence the risk of developing cancers that can be treated early. The goal is to find out if this knowledge can help doctors and health insurers improve their methods for preventing cancers that cannot be treated.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Kenneth S Ramos, MD
- Telefonnummer: 7136777740
- E-mail: kramos@tamu.edu
Undersøgelse Kontakt Backup
- Navn: Rick Silva, PhD
- Telefonnummer: (713) 677-7422
- E-mail: ricksilva@tamu.edu
Studiesteder
-
-
Texas
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Bryan, Texas, Forenede Stater, 77802
- Rekruttering
- Texas A&M Family Care
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Ledende efterforsker:
- Kenneth S Ramos, MD, PhD
-
Underforsker:
- Rick Silva, PhD
-
Underforsker:
- Fen Wang, PhD
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Underforsker:
- Marcia Ory, PhD
-
Kontakt:
- De Lona A Bacote, MS
- Telefonnummer: 7136777735
- E-mail: dabacote@tamu.edu
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Kontakt:
- Gabriel Neal, MD
- Telefonnummer: 9794360399
- E-mail: gneal@tamu.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
TREC@TAMU Registry will recruit as many participants as possible. The estimated enrollment in five years is expected to be 2500, but investigators will not limit recruitment if that number is exceeded.
Beskrivelse
Inclusion Criteria:
- 18 years of age and older, and,
- People participating in the Cancer Prevention and Research Institute of Texas (CPRIT) A coordinated cancer screening research program in Bryan and Navasota Family Medicine Clinics and,
- People with COPD, liver disease, cervical intraepithelial neoplasia (CIN) lesions, having had a colonoscopy or a low dose computed tomography (LDCT) lung scan or cervical exam in the last 12 months or scheduled for one, and,
- Able to give and comprehend the consent process, and,
- Able to consent to donate blood and urine samples, genetic material through buccal swabs for future research, and,
- Able to understand that their specimens, health record, and changes in health status will be followed for a five-year period and shared in deidentified form with the research community, and,
- All sexes and gender identities.
Exclusion Criteria:
- Declines to participate or interact with staff/share their medical status.
- A diagnosis of Alzheimer's disease or related dementias in a medical record indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning Individuals who are unable or unwilling to provide consent will be excluded
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: OTHER
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency and nature of ADRs on the Naranjo Scale Questionnaire
Tidsramme: 5 years
|
Measure the frequency and nature of adverse drug reactions by obtaining a complete medical history and physical examination and validating the patient's current concomitant medication list during the office visit. Patient medical information would be input into the ActX platform, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of ADRs using the Naranjo Scale will be conducted for the duration of the study. |
5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported Health status and any significant changes
Tidsramme: 5 years
|
The EQ-5D-5L survey, designed to collect data on health status and significant changes, will be administered to every patient in the registry at each clinic visit and at least every six months for five years after enrollment. The EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension features five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Patients indicate their health state by ticking the box next to the most appropriate statement for each dimension. This choice generates a one-digit number representing the selected level for that dimension. The numbers from the five dimensions can be combined into a five-digit number that characterizes the patient's health state. |
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY2024-0008
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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