Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
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
- Concordance between a recurrence and ctDNA status
研究概览
简要总结
This study investigates the feasibility of the Labcorp Plasma Detect, which is an assay (test) that looks for circulating tumor DNA (ctDNA) in patients who have muscle-invasive (MI) urothelial carcinoma (also known as MI bladder cancer, MIBC). During this study, tissue, blood and urine samples will also be analyzed to help the study team better understand this type of cancer and a patient's response to treatment.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the correspondence of cancer recurrence and ctDNA positivity.
OUTLINE: This is an observational study. Patients will undergo prospective sample collection of blood, tissue, and urine to assess levels of tumor DNA based on whole genome sequencing of their cancer. Their medical records will be reviewed on study to see whether levels of ctDNA correlate with disease response to treatment or recurrence.
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
- •Ability to understand and willingness to provide written informed consent
- •Age ≥ 18 yr at the time of consent. Eligibility is limited to adults since MIBC is not prevalent in persons under the age of 18 yr. Persons of all genders, gender identities, races, and ethnicity will be included
- •New diagnosis of histologically confirmed muscle-invasive UC (TNM classification (UICC/AJCC 8th edition) of cT2-4aN0-2M0 at pathological examination and approved for either (1) systemic NAT followed by RC or (2) CRT
- •Plan for treatment of MIBC with curative intent with one of the three SOC treatments as listed above
- •Surgical resection, if planned, must include removal of the bladder and bilateral pelvic lymph node dissection if not already included
- •Radiation therapy, if planned, must include transurethral resection of bladder tumor, followed by image guided radiotherapy plus sensitizing chemotherapy
- •Representative FFPE tumor specimens from biopsy at diagnosis (including TURBT) in paraffin blocks (blocks preferred) or at least 10 unstained and 1 H&E slides. Biopsied tumor specimen quality must have been verified by local pathology review. Fine-needle aspiration, brushing, cell pellet from pleural effusion, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation
- •For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must follow guidelines and recommendations per the SOC for their various therapeutic interventions
排除标准
- •Ongoing treatment with an approved or investigational anti-cancer therapy for a cancer that is distinct from UC. Hormone-replacement therapy or oral contraceptives are allowed. Ongoing systemic therapy for bladder cancer will not be exclusionary, but enrollment of this population will be limited
- •Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma, low or intermediate risk prostate cancer under active surveillance, myeloproliferative disorders or indolent hematologic malignancies that do not require active systemic therapy, and small renal masses under active surveillance. Any cancer curatively treated >two years prior to the first treatment for bladder cancer is permitted
研究组 & 干预措施
Observational
Patients undergo blood, tissue, and urine sample collection and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Concordance between a recurrence and ctDNA status
时间窗: Up to study completion. Up to 5 years with the continuation of Years 4-5 study activities based on the results of the Year 3 interim review
Will assess the concordance between a recurrence (assigned using SOC methods) and ctDNA status post definitive treatment among participants who have demonstrated cancer recurrence. Concordance will be evaluated using a time-dependent C index and diagnostic accuracy will be reported with sensitivity, specificity, PPV, and NPV.
次要结局
未报告次要终点
研究者
Jen-Jane Liu, M.D.
Principal Investigator
OHSU Knight Cancer Institute