UNC Barrett's Esophagus and Esophageal Cancer Biorepository
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Data
研究概览
简要总结
Aim 1: To develop a prospective tissue and blood biorepository from patients with a history of Barrett's Esophagus (BE) or esophageal cancer (ECA) presenting to UNC hospitals for routine care upper endoscopy for their condition.
Aim 2: To collect clinical data from patients with a history of Barrett's Esophagus (BE) or esophageal cancer (ECA) that includes demographic data, endoscopic procedure data, and pathology data.
Aim 3: To integrate Aim 1 and 2 in a manner that will provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.
Aim 4: To create a biorepository for future Institutional Review Board (IRB) approved studies that have tissue and/or blood specimen component.
详细描述
Patients will be identified during GI clinic visits or procedure visits with Dr. Nicholas Shaheen or his colleagues at UNC. Patients may also be identified by research personnel during review of the endoscopy schedule and medical records. If eligible, interested participants will be provided with a consent form during their clinic or procedure visit. Enrolled subjects will be assigned a unique identification (ID) number for data collection.
Patients will be recruited by Dr. Nicholas Shaheen and his colleagues or by other study personnel prior to their routine care endoscopy at UNC. An investigator, study coordinator, or other personnel trained in the protocol and referenced in the IRB application will obtain consent during the patient's visit in the GI clinic or prior to an upper endoscopy. Potential subjects will have an opportunity to carefully review the consent form, the details of the study will be reviewed verbally, and all questions will be answered to the satisfaction of the patient. Only English-speaking adults with the ability to consent will be eligible for enrollment in this study. After the subject signs the consent, a copy of the signed consent will be provided to the subject and the coordinator will collect demographic and historical information from the patient pertaining to illnesses, medication and other relevant information. The consent process will be documented in the subject's research file.
After obtaining informed consent, blood will be obtained and subjects will proceed with their routine care upper endoscopy. The endoscopist, as per routine practice, will note findings in the procedure report and photograph or record video to confirm and document key findings, as well as take biopsies as indicated for routine care. During the procedure up to 10 research biopsies will be collected as part of this study. Research biopsies will be collected in addition to routine care biopsies and will be obtained with a standardized biopsy protocol (below). The total number of research biopsies may vary based on presence/absence of nodularity but will not exceed 10 research-specific biopsies. This number of esophageal biopsies is within the standard of care for biopsying the esophagus.
Biopsies for clinical care are taken prior to any consideration of research biopsies. Research biopsies are taken only if the additional biopsies do not significantly increase the patient's risk or interfere with routine care procedures. The research biopsy protocol may be modified by the physician performing the procedure if necessary.
In addition to research blood and biopsies, up to 4 cytology brushings for research purposes may also be obtained during the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 and older.
- •Able to read, comprehend, and complete the informed consent form.
- •Presenting to UNC hospitals for routine care upper endoscopy for their condition.
- •Meet one of the following:
- •Current or previous diagnosis of Barrett's Esophagus (BE) with or without dysplasia OR
- •Current or previous diagnosis of esophageal cancer (including esophageal adenocarcinoma, intramucosal carcinoma, and squamous cell carcinoma)
- •Willing to undergo biopsy and blood collection for research purposes.
排除标准
- •Unable to read or understand English.
- •Current incarceration.
- •Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after esophagogastroduodenoscopy [EGD] and/or ensuring blood thinners have been stopped within an appropriate time frame for that specific agent and in accordance with standard clinical practice).
- •Known bleeding disorder.
结局指标
主要结局
Data
时间窗: 10 years
To collect clinical data from patients with a history of Barrett's Esophagus (BE) or esophageal cancer (ECA) that includes demographic data, endoscopic procedure data, and pathology data.
Collaboration with other investigators
时间窗: 10 years
integrate Aim 1 and 2 in a manner that will provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.
Specimen Biorepository
时间窗: 10 years
To develop a prospective tissue and blood biorepository from patients with a history of Barrett's Esophagus (BE) or esophageal cancer (ECA) presenting to UNC hospitals for routine care upper endoscopy for their condition. To create a biorepository for future IRB approved studies that have a tissue and/or blood specimen component.
次要结局
未报告次要终点