Ascites, Malignant, Carcinoma, Carcinoma Bladder, Carcinoma Breast, Carcinoma, Hepatocellular, Carcinoma, Neuroendocrine, Carcinoma, Non-Small-Cell Lung, Carcinoma of Esophagus, Carcinoma of the Anus, Carcinoma of the Appendix, Carcinoma of the Bladder, Carcinoma of the Cervix, Carcinoma of the Head and Neck, Carcinoma of the Larynx, Carcinoma of the Nasopharynx, Carcinoma of the Oral Cavity, Carcinoma of the Oropharynx, Carcinoma of the Penis, Carcinoma of the Vulva, Carcinoma of Unknown Primary, Carcinoma, Ovarian, Carcinoma, Pancreatic, Carcinoma, Pancreatic Ductal, Carcinoma, Renal, Carcinoma, Renal Cell, Carcinoma, Small Cell, Carcinoma, Thymic, Cholangiocarcinoma, Melanoma, Mesothelioma, Pancreatic Cancer, Pleural Effusion, Malignant
Conditions
Keywords
Breast Cancer, Lung Cancer, NSCLC, Occult Cancer, Ovarian Cancer, Melanoma, Mesothelioma, Gastrointestinal Stromal Tumor, Gastric Cancer, Colon Cancer, Cervical Cancer
Brief summary
The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patient is ≥18 years of age 2. Written Informed Consent provided by patient 3. Diagnosis of any kind of carcinoma 4. Malignant fluid (e.g. pleural effusion or ascites) drainage OR tumor tissue resection OR tumor tissue needle biopsy is clinically indicated as part of SOC 5. Proceeding onto therapy for treatment 6. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)
Exclusion criteria
1. Lack of informed consent 2. Unable to obtain sufficient sample
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BOR | 12 months | Best overall response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 24 months | Progression Free Survival |
Countries
United States
Contacts
Travera Inc
Travera Inc