IRB Study Number 21-775
Status Recruiting
Phase Phase 1
Institute Taussig Cancer Institute
Description
Primary Objectives
To compare rate of distant recurrence in each of the primary cohorts as measured by the post-treatment Guardant MRD assay results (ctDNA detected vs. not detected)
Secondary Objectives
To assess the clinical performance of the Guardant MRD assay to predict recurrence in each of the primary cohorts
Inclusion Criteria
● Age > 18 years old AND
● Initial treatment is being given with curative/radical intent AND
● Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND
● Provided written informed consent to participate in the study AND
● Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND
● Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND
● Have at least one Landmark blood sample collected. Landmark samples are collected 3- 12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant’s planned treatment regimen
● Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:
III.1.1 Primary Study Cohorts
● Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
● Cohort 2: Non-small cell lung cancer (stage IB-III)
● Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one of the following:
o Cohort 3A: High-risk HER2+ breast cancer (any ER, PR status allowed); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR
o Cohort 3B: High-risk triple negative breast cancer (TNBC); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR
o Cohort 3C: HR-positive/HER2-negative invasive breast carcinoma with either >4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes and at least one of the following: tumor size >5 cm, histologic grade 3, or validated gene expression assay indicating high recurrence risk (OncotypeDx score > 26, MammaPrint high, ProSigna high, EndoPredict high)
III.1.2 Exploratory Cohorts
● Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent
● Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
● Cohort 6: Gastric adenocarcinoma (stage II-III)
● Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection
● Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus)
● Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology)
● Cohort 10: High-risk endometrial carcinoma (defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology))
● Cohort 11: High-risk renal cell carcinoma (defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)
● Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapyor immunotherapy- containing regimen
Exclusion Criteria
● History of allogeneic organ or tissue transplant
● Index cancer has predominantly neuroendocrine histology
● History of another primary cancer diagnosed within 3 years from the date of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate-risk prostate cancers (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), and stage I papillary thyroid carcinoma, and participants with bilateral/multifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment.
● Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)
● Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence
