Cancer of the Cervix, Cancer of the Pancreas, Cervical Cancer, Locally Advanced Cervical Cancer, Locally Advanced Cervical Carcinoma, Locally Advanced Pancreas Cancer, Locally Advanced Pancreatic Cancer, Locally Advanced Pancreatic Carcinoma, Pancreas Cancer, Pancreatic Cancer
Conditions
Keywords
Radiotherapy, Chemotherapy, Cervical cancer, Pancreatic cancer, Biospecimen
Brief summary
This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.
Interventions
OTHERTumor collection via biopsy
Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.
OTHERBlood collection
Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence
DEVICEDiffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)
Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence. The imaging will be performed when possible.
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
The Foundation for Barnes-Jewish Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
30 cervical cancer patients and 30 pancreatic cancer patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmation of intent to receive radiotherapy for one of the following diagnoses: * Cervical cancer * Pancreatic cancer * ECOG performance status ≤ 2 * At least 18 years old * Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion criteria
* Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tumor microenvironment | From start of follow-up through completion of follow-up (estimated to be 5 years) | Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time. |
Countries
United States
Contacts
CONTACTMichael Waters, M.D., Ph.D.
PRINCIPAL_INVESTIGATORMichael Waters, M.D., Ph.D.
Washington University School of Medicine
Outcome results
None listed