NCT05461430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

July 13, 2022

Last Update Submit

April 7, 2026

Conditions

Ascites, MalignantCarcinomaPleural Effusion, MalignantCarcinoma, HepatocellularCarcinoma, Renal CellCarcinoma, RenalCarcinoma, Small CellCarcinoma, Non-Small-Cell LungCarcinoma, Pancreatic DuctalCarcinoma, NeuroendocrineCarcinoma, ThymicCarcinoma, PancreaticCarcinoma BreastCarcinoma, OvarianCarcinoma BladderCarcinoma of Unknown PrimaryCarcinoma of the Head and NeckCarcinoma of the OropharynxCarcinoma of the LarynxCarcinoma of the BladderCarcinoma of EsophagusCarcinoma of the NasopharynxCarcinoma of the PenisCarcinoma of the CervixCarcinoma of the AnusCarcinoma of the VulvaCarcinoma of the AppendixCarcinoma of the Oral CavityCholangiocarcinomaMelanomaMesotheliomaPancreatic Cancer

Keywords

Breast CancerLung CancerNSCLCOccult CancerOvarian CancerMelanomaMesotheliomaGastrointestinal Stromal TumorGastric CancerColon CancerCervical Cancer

Outcome Measures

Primary Outcomes (1)

  • BOR

    Best overall response

    12 months

Secondary Outcomes (1)

  • PFS

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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)

You may not qualify if:

  • Lack of informed consent
  • Unable to obtain sufficient sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

xCures

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Pleural Effusion, MalignantAscitesCarcinomaCarcinoma, HepatocellularCarcinoma, Renal CellCarcinoma, Small CellCarcinoma, Non-Small-Cell LungCarcinoma, Pancreatic DuctalCarcinoma, NeuroendocrineThymomaPancreatic NeoplasmsBreast NeoplasmsOvarian NeoplasmsUrinary Bladder NeoplasmsNeoplasms, Unknown PrimaryOropharyngeal NeoplasmsLaryngeal NeoplasmsEsophageal NeoplasmsNasopharyngeal NeoplasmsPenile NeoplasmsUterine Cervical NeoplasmsAnus NeoplasmsVulvar NeoplasmsAppendiceal NeoplasmsMouth NeoplasmsCholangiocarcinomaMelanomaMesotheliomaLung NeoplasmsGastrointestinal Stromal TumorsStomach NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinomaLiver NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung DiseasesCarcinoma, DuctalNeoplasms, Ductal, Lobular, and MedullaryEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Complex and MixedThymus NeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesGonadal DisordersUrinary Bladder DiseasesNeoplasm MetastasisNeoplastic ProcessesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesGastrointestinal NeoplasmsEsophageal DiseasesGastrointestinal DiseasesNasopharyngeal DiseasesGenital Neoplasms, MaleGenital Diseases, MalePenile DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsIntestinal DiseasesAnus DiseasesRectal DiseasesVulvar DiseasesCecal NeoplasmsCecal DiseasesMouth DiseasesNevi and MelanomasSkin NeoplasmsAdenomaNeoplasms, MesothelialNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueStomach DiseasesColonic Diseases

Study Officials

  • Mark Stevens, Phd

    Travera Inc

    PRINCIPAL INVESTIGATOR

  • Rob Kimmerling, Phd

    Travera Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 18, 2022

Study Start

July 15, 2022

Primary Completion

March 23, 2026

Study Completion

March 23, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)