Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas

Официальное название

Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology

Обзор

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.

Вмешательства

• Другое Blood Sample collection
  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).
• Другое Tissue sample collection
  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.
• Другое Data collection
  Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.

Первичные конечные точки

• Predictive value of CT Radiomic features vs conventional radiologic features [Срок оценки: Up to 2 years]
• Development of Clinical Decision Making Models for Predicting IPMN Pathology [Срок оценки: Up to 2 years]
• Radiogenomic Analyses [Срок оценки: Up to 2 years]

Вторичные конечные точки (2)

• Overall Survival [Срок оценки: Up to 4 years]
• Progression Free Survival [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 3 центра

• Florida Research Institute (FRI) — Lakewood Rch
• Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital — Miami
• Moffitt Cancer Center — Tampa

Идентификаторы

NCT: NCT04275557 · MCC-20105 · 1R37CA229810-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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