Bruk av radiogenomikk for å forutsi ondartet potensiale av intraduktale papillære mucinøse neoplasmer i bukspyttkjertelen
Bruk av radiogenomikk for ikke-invasivt å forutsi det ondartede potensialet til intraduktale papillære mucinøse neoplasmer (IPMN) i bukspyttkjertelen og avdekke skjult biologi
The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Florida
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Lakewood Rch, Florida, Forente stater, 34211
- Florida Research Institute (FRI)
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Miami, Florida, Forente stater, 33136
- Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
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Tampa, Florida, Forente stater, 33612
- Moffitt Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.
Beskrivelse
Inclusion Criteria:
- Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.
- Able to understand and voluntarily sign the informed consent.
- Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document
Exclusion Criteria:
- No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.
- Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).
- Unable to provide informed consent.
- Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_ONLY
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Retrospective Cohort
Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases |
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Prospective Cohort
Blood, tumor tissue samples and data will be collected. |
Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date), 4-6 weeks post-surgery, if applicable, and at the time of follow-up (approximately 1 year and approximately 2 years after baseline). At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue, muscle, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected. Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Predictive value of CT Radiomic features vs conventional radiologic features
Tidsramme: Up to 2 years
|
Preoperative CT images will be evaluated for a retrospective cohort of at least 254 pathologically-confirmed IPMN cases (approximately 190 malignant characterized by high-grade dysplasia or invasion and approximately 64 benign characterized by low- or moderate-grade dysplasia). 3D-radiomic features will be extracted with the new Quantitative Imaging Decision Support (QIDS)™ platform (Healthmyne, Inc.) and associations will be evaluated with pathology. |
Up to 2 years
|
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Development of Clinical Decision Making Models for Predicting IPMN Pathology
Tidsramme: Up to 2 years
|
Investigators will develop the first prototype preoperative 'omics'-based nomograms to predict IPMN pathology by integrating radiomic features, the MGC, and other covariates. Emphasis will be placed on developing nomograms for individuals whose IPMNs appear to have 'worrisome' radiologic features which are very challenging to manage. |
Up to 2 years
|
|
Radiogenomic Analyses
Tidsramme: Up to 2 years
|
Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers. |
Up to 2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: Up to 4 years
|
Overall survival is defined as time from surgery to death from any cause. |
Up to 4 years
|
|
Progression Free Survival
Tidsramme: Up to 4 years
|
Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death. |
Up to 4 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jennifer Permuth, PhD, Moffitt Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Neoplasmer i endokrine kjertel
- Pankreassykdommer
- Cyster
- Neoplasmer i bukspyttkjertelen
- Bukspyttkjertelcyste
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Datainnsamling
Andre studie-ID-numre
- MCC-20105
- 1R37CA229810-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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