Naturlig historia av medullär sköldkörtelcancer för att informera om avancerad sjukdomshantering
Utnyttjande av den naturliga historien om medullär sköldkörtelkarcinom för att informera om avancerad sjukdomshantering
This study utilizes a multi-institutional registry to describe the natural history of medullary thyroid cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) in understanding disease management. The goal of this study is to learn about how medullary thyroid cancer develops and progresses.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. To describe the natural history of medullary thyroid cancer (MTC) using a comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in our existing multi-institutional patient registry.
Ia. To describe the demographic, clinical, pathologic, and genotypic variables associated with each phase of disease.
Ib. To identify those variables which are predictors of progression to the most advanced phases of disease that require small molecule therapy, including commercially approved and experimental agents.
II. To characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).
IIa. To describe clinical, psychosocial, economic, and physical well-being variables and the subsequent impact on quality of life associated with each phase of disease.
IIb. To evaluate longitudinal changes in clinical, psychosocial, economic, and physical well-being variables between and within all phases of MTC, and the subsequent impact they have on quality of life.
III. To evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.
OUTLINE:
AIM I & II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.
AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.
The questionnaire data gets paired with the collected medical record history that is maintained in the Registry.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Elizabeth G Grubbs
- Telefonnummer: 713-792-6940
- E-post: eggrubbs@mdanderson.org
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94143
- Rekrytering
- University of California San Francisco
-
Kontakt:
- Julie A. Sosa
- Telefonnummer: 415-476-1236
-
Huvudutredare:
- Julie A. Sosa
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Rekrytering
- M D Anderson Cancer Center
-
Kontakt:
- Elizabeth G. Grubbs
- Telefonnummer: 713-792-6940
- E-post: eggrubbs@mdanderson.org
-
Huvudutredare:
- Elizabeth G. Grubbs
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients diagnosed with MTC including advanced phase MTC determined by clinical team
Beskrivning
Inclusion Criteria:
- Aims 1 and 2: A diagnosis of MTC
- Aims 1 and 2: A registrant in the Medullary Thyroid Cancer Registry (MTCR). Patients of all disease phases will be eligible for enrollment
- Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team
- Aim 3: A current registrant in the MTCR
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Observational (questionnaire, blood pressure)
AIM I & II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease. AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks. |
Complete questionnaires Undergo blood pressure measurement |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Natural history of medullary thyroid cancer (MTC)
Tidsram: Up to 4 years
|
Will describe the natural history of MTC using comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in existing multi-institutional patient registry. |
Up to 4 years
|
|
Patients' experience with the different phases of MTC
Tidsram: Up to 4 years
|
Will characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs). |
Up to 4 years
|
|
Association of selected biometric and patient-reported outcomes
Tidsram: Up to 4 years
|
Will evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial. |
Up to 4 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Elizabeth G Grubbs, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2019-0769
- 2019-0769 (Annan identifierare: M D Anderson Cancer Center)
- NCI-2019-07526 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
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