Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Complete clinical response (cCR)
研究概览
简要总结
This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the percentage of participants that achieve complete clinical response.
SECONDARY OBJECTIVES:
I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT).
II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS).
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
- •Participant must provide written informed consent before any study-specific procedures or interventions are performed
- •Participants aged >= 18 years
- •Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:
- •T3N0M0 - T4bN2M0
排除标准
- •Has radiologic evidence of distant metastases at the time of screening/enrollment
- •Has received prior treatment for their rectal adenocarcinoma
- •Requires or has received blood transfusion within 1 month of study enrollment
结局指标
主要结局
Complete clinical response (cCR)
时间窗: From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months.
cCR following TNT will be analyzed using the TNT analysis set. Proportions of participants that achieved cCR will be calculated and the exact 95% confidence interval (CI) will be presented.
次要结局
- Rate of transabdominal surgery(Up to 3 years following completion of TNT)
- Rate of watch and wait strategy(Up to 3 years following completion of TNT)
- Overall survival(Time between the date of signed consent to the date of death from any cause, assessed up to 3 years following completion of TNT)
- Positive circulating tumor deoxyribonucleic acid (ctDNA)(From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years.)
- Rate of pathological complete response (pCR)(From start of treatment until completion of surgery, up to 3 years.)
- Disease-free survival(Time between the date of surgery (or W&W population, the date of completing TNT) and the date of local or metastatic recurrence or death from any cause, assessed up to 3 years following completion of TNT)
- Positive ctDNA after completing TNT(From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years)
研究者
Adel Kardosh M.D., Ph.D.
Principal Investigator
OHSU Knight Cancer Institute