NCT04281381招募中不适用
A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.
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
- •Clinical diagnosis of desmoid fibromatosis, either new or newly recurrent. Both patients with sporadic and FAP-associated disease will be eligible for inclusion. Patients with clinical diagnosis of desmoid (as assessed by MSK physician) but without pathologic diagnosis may be enrolled on the study to facilitate acquisition of appropriately protocoled baseline scans and allow for biospecimen collection; these patients will be replaced for purposes of analysis if pathology does not confirm clinical diagnosis.
- •At least 18 years of age.
- •Able to undergo cross-sectional imaging by either MRI or CT with intravenous contrast
- •Disease detectable on cross-sectional imaging with target lesion measuring >/= 1 cm
- •Eligible for management by active observation as assessed by primary MSK care provider
- •Willing and able to sign an informed consent document
排除标准
- •Symptomatic desmoid fibromatosis requiring narcotic pain control, resulting in intestinal fistulization, or requiring inpatient admission during the 3 months prior to enrollment
- •Patients with intraabdominal desmoids greater than 7cm in diameter or localized within 1cm of the central mesenteric vessels and those with tumors in the head and neck
- •KPS performance status </= 70 if performance status is limited due to tumor. Patients with low KPS performance status related to co-morbidities but without symptoms related to the tumor will be eligible for enrollment.
- •Age less than 18 years old
- •Strict contraindication for both cross-sectional MRI and CT imaging with intravenous contrast (e.g., as per standard institutional protocols regarding renal insufficiency or MRI incompatible implanted devices; patients requiring pre-medication to prevent contrast reactions will be eligible for study)
- •Unable to grant reliable informed consent
- •Ongoing systemic treatment for desmoid fibromatosis
研究组 & 干预措施
Desmoid Fibromatosis
Participants will have a clinical diagnosis of desmoid fibromatosis, either new or newly recurrent
干预措施: Cross-sectional imaging (Diagnostic Test)
结局指标
主要结局
Progression free survival
时间窗: 12 months
The primary objective of this study is to estimate progression-free survival at 12 months, with the events defined by progression via radiographic criteria (RECIST 1.1).
次要结局
未报告次要终点
研究者
研究点 (1)
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