Pleural Effusion, MalignantTraveraRTGxNCT05461430
Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)
An observational study of Pleural Effusion, Malignant and Ascites, Malignant, run by Travera Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant, Ascites, Malignant, Carcinoma
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 23 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Lack of informed consent
- Unable to obtain sufficient sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pleural Effusion, Malignant, Ascites, Malignant, Carcinoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Carcinoma, Renal
- Keywords
- Breast Cancer, Lung Cancer, NSCLC, Occult Cancer, Ovarian Cancer, Melanoma, Mesothelioma, Gastrointestinal Stromal Tumor, Gastric Cancer, Colon Cancer, Cervical Cancer
- Medical subject headings
- Pleural Effusion, Malignant, Ascites, Carcinoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Carcinoma, Small Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Pancreatic Ductal
What is being measured
The primary outcome is the main question the study is designed to answer.
BOR
Best overall response
Measured: 12 months
Secondary outcomes (1)
PFS
Progression Free Survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start15 Jul 2022
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travera Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- xCures
- Responsible party
- Sponsor
- Investigators
- Mark Stevens, Phd, Principal investigator, Travera IncRob Kimmerling, Phd, Principal investigator, Travera Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461430
- Sponsor's protocol ID
- TRV-003
- Acronym
- TraveraRTGx
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance
- ClinicalTrials.gov ID
- NCT05461430
- Acronym / sponsor ID
- TraveraRTGx / TRV-003
- Conditions
- Pleural Effusion, Malignant, Ascites, Malignant, Carcinoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Carcinoma, Renal
- Keywords
- Breast Cancer, Lung Cancer, NSCLC, Occult Cancer, Ovarian Cancer, Melanoma, Mesothelioma, Gastrointestinal Stromal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Travera IncIndustry (pharma, biotech, devices)
- Collaborators
- xCures
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of informed consent
- Unable to obtain sufficient sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BOR
Time frame: 12 months
Best overall response
1 secondary outcome
PFS
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Stevens, Phd principal investigator
Travera Inc
Rob Kimmerling, Phd principal investigator
Travera Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, Malignant and Ascites, Malignant, run by Travera Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOR (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.