- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05461430
Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx) (TraveraRTGx)
April 7, 2026 updated by: Travera Inc
Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance
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.
Study Overview
Status
Completed
Conditions
- Melanoma
- Carcinoma, Renal Cell
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Hepatocellular
- Carcinoma, Pancreatic
- Pancreatic Cancer
- Mesothelioma
- Cholangiocarcinoma
- Carcinoma, Neuroendocrine
- Carcinoma, Small Cell
- Pleural Effusion, Malignant
- Carcinoma, Pancreatic Ductal
- Carcinoma of the Appendix
- Carcinoma Breast
- Carcinoma of Unknown Primary
- Carcinoma of the Oral Cavity
- Carcinoma of the Oropharynx
- Carcinoma, Thymic
- Ascites, Malignant
- Carcinoma, Ovarian
- Carcinoma Bladder
- Carcinoma of Esophagus
- Carcinoma of the Head and Neck
- Carcinoma of the Anus
- Carcinoma of the Larynx
- Carcinoma of the Penis
- Carcinoma of the Vulva
- Carcinoma, Renal
- Carcinoma of the Bladder
- Carcinoma of the Nasopharynx
- Carcinoma of the Cervix
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Oakland, California, United States, 94612
- xCures
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
This pilot study will utilize samples from as many as 200 patients with a known carcinoma undergoing routine draining of malignant fluids or sampling of their tumor tissue for diagnostic or palliative standards of care (SOC).
Description
Inclusion Criteria:
- Patient is ≥18 years of age
- Written Informed Consent provided by patient
- Diagnosis of any kind of carcinoma
- 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
- Proceeding onto therapy for treatment
- Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)
Exclusion Criteria:
- Lack of informed consent
- Unable to obtain sufficient sample
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOR
Time Frame: 12 months
|
Best overall response
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS
Time Frame: 24 months
|
Progression Free Survival
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Stevens, Phd, Travera Inc
- Principal Investigator: Rob Kimmerling, Phd, Travera Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2022
Primary Completion (Actual)
March 23, 2026
Study Completion (Actual)
March 23, 2026
Study Registration Dates
First Submitted
July 13, 2022
First Submitted That Met QC Criteria
July 13, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Pathologic Processes
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Rectal Diseases
- Uterine Diseases
- Genital Diseases, Female
- Lung Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Pancreatic Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Neoplastic Processes
- Esophageal Diseases
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Urologic Neoplasms
- Uterine Cervical Diseases
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Uterine Neoplasms
- Neuroendocrine Tumors
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Connective Tissue
- Nevi and Melanomas
- Skin Neoplasms
- Urinary Bladder Diseases
- Neoplasms, Complex and Mixed
- Laryngeal Diseases
- Vulvar Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Neoplasm Metastasis
- Anus Diseases
- Penile Diseases
- Pleural Diseases
- Cecal Neoplasms
- Cecal Diseases
- Carcinoma, Ductal
- Rectal Neoplasms
- Thymus Neoplasms
- Pleural Effusion
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Stomach Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Lung Neoplasms
- Colonic Neoplasms
- Esophageal Neoplasms
- Ovarian Neoplasms
- Mesothelioma
- Breast Neoplasms
- Pancreatic Neoplasms
- Carcinoma, Renal Cell
- Carcinoma, Non-Small-Cell Lung
- Uterine Cervical Neoplasms
- Cholangiocarcinoma
- Nasopharyngeal Neoplasms
- Carcinoma, Neuroendocrine
- Melanoma
- Urinary Bladder Neoplasms
- Carcinoma, Small Cell
- Laryngeal Neoplasms
- Mouth Neoplasms
- Vulvar Neoplasms
- Oropharyngeal Neoplasms
- Gastrointestinal Stromal Tumors
- Neoplasms, Unknown Primary
- Anus Neoplasms
- Thymoma
- Penile Neoplasms
- Pleural Effusion, Malignant
- Appendiceal Neoplasms
- Ascites
- Carcinoma, Pancreatic Ductal
Other Study ID Numbers
- TRV-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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