Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug
研究概览
简要总结
This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.
详细描述
PRIMARY OBJECTIVE:
I. To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.
OUTLINE:
Patients who participated in MAY2016-07-01 undergo review of medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MAY2016-07-01 study participants for whom medical records are available and accessible
排除标准
- •MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented
研究组 & 干预措施
Observational (medical record review)
Patients who participated in MAY2016-07-01 undergo review of medical records.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug
时间窗: At completion of study
Will be assessed by endoscopy.
Number of participants who underwent surgical resection
时间窗: At completion of study
Will determine the number of participants who underwent surgical resection for management of advanced upper gastrointestinal (GI) neoplasia/cancer between the date of completion of intervention and 2/28/2021.
Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms
时间窗: At completion of study
次要结局
- Number of participants with evidence of progression of upper GI disease(At completion of study)