NCT04985357

Brief Summary

The primary objective of this study, sponsored by Travera 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 varying cancers and biopsy formats.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
49mo left

Started Nov 2024

Longer than P75 for all trials

Status
withdrawn

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

Study Progress28%
Nov 2024May 2030

First Submitted

Initial submission to the registry

July 15, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
3.3 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

July 15, 2021

Last Update Submit

November 21, 2024

Conditions

Stage III Breast CancerStage IV Breast CancerStage III Lung CancerStage IV Lung CancerAMLMultiple Myeloma in RelapseCarcinomaCarcinoma, PancreaticCarcinoma of LungCarcinoma, Non-Small-Cell LungCarcinoma BreastCarcinoma ProstateCarcinoma, HepatocellularCarcinoma, Renal CellCarcinoma, NeuroendocrineCarcinoma, Small Cell LungCarcinoma, OvarianCarcinoma BladderCarcinoma of EsophagusCarcinoma CervixCarcinoma, ThymicCarcinoma, DuctalCarcinoma of the Head and NeckCarcinoma of the LipCarcinoma of the Oral CavityCarcinoma of Unknown PrimaryCarcinoma of the SkinCarcinoma of the AnusCarcinoma of the LarynxCarcinoma of the PenisCarcinoma of the OropharynxCarcinoma of the AppendixCarcinoma of the Paranasal SinusCarcinoma of the VulvaMalignant Pleural EffusionMalignant AscitesMesotheliomaCholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Best overall response (BOR)

    The best overall response to therapy over 24 months will be captured for correlation with test outcomes.

    up to 24 months

Study Arms (6)

Carcinoma-Associated Malignant Fluid

Diagnosis of any kind of carcinoma with a malignant fluid (pleural effusion or ascites) where drainage is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Carcinoma Solid Tissue Specimen

Diagnosis of any kind of carcinoma where a needle biopsy or tissue resection is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Multiple Myeloma

Diagnosis of relapsed multiple myeloma where bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Acute myelogenous leukemia (AML)

Diagnosis of acute myelogenous leukemia where a blood draw or bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Triple Negative Breast Cancer (TNBC)

Diagnosis of Stage IV Triple Negative Breast Cancer where a needle biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.

Peripheral Blood Cell Immune Competency

Diagnosis of any cancer where a blood draw is clinically indicated as part of SOC, a new course of treatment is upcoming, and checkpoint inhibitor therapy being considered for next line of treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population with cohort matched diagnoses.

You may qualify if:

  • Sample collection or biopsy of tumor is clinically indicated as part of SOC
  • Prior to preceding onto therapy for treatment

You may not qualify if:

  • Unable to obtain sufficient sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsCarcinomaPancreatic NeoplasmsCarcinoma, Non-Small-Cell LungProstatic NeoplasmsCarcinoma, HepatocellularCarcinoma, Renal CellCarcinoma, NeuroendocrineSmall Cell Lung CarcinomaOvarian NeoplasmsUrinary Bladder NeoplasmsEsophageal NeoplasmsUterine Cervical NeoplasmsThymomaCarcinoma, DuctalLip NeoplasmsMouth NeoplasmsNeoplasms, Unknown PrimaryAnus NeoplasmsLaryngeal NeoplasmsPenile NeoplasmsOropharyngeal NeoplasmsAppendiceal NeoplasmsParanasal Sinus NeoplasmsVulvar NeoplasmsPleural Effusion, MalignantMesotheliomaCholangiocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesAdenocarcinomaLiver NeoplasmsLiver DiseasesKidney NeoplasmsUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersUrinary Bladder DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsEsophageal DiseasesGastrointestinal DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesNeoplasms, Complex and MixedThymus NeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms, Ductal, Lobular, and MedullaryLip DiseasesMouth DiseasesStomatognathic DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsIntestinal DiseasesAnus DiseasesRectal DiseasesOtorhinolaryngologic NeoplasmsLaryngeal DiseasesOtorhinolaryngologic DiseasesPenile DiseasesPharyngeal NeoplasmsPharyngeal DiseasesCecal NeoplasmsCecal DiseasesNose NeoplasmsNose DiseasesParanasal Sinus DiseasesVulvar DiseasesPleural NeoplasmsPleural EffusionPleural DiseasesAdenomaNeoplasms, Mesothelial

Study Officials

  • Mark Stevens, Ph.D.

    Travera Inc

    PRINCIPAL INVESTIGATOR

  • Robert Kimmerling, Ph.D.

    Travera Inc

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

July 15, 2021

First Posted

August 2, 2021

Study Start

November 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share