NCT06081517

Brief Summary

This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,600

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress47%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

August 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

4.9 years

First QC Date

August 23, 2023

Last Update Submit

June 10, 2025

Conditions

Metastatic CancerAdvanced Cancer

Keywords

Precision MedicineDisparities

Outcome Measures

Primary Outcomes (2)

  • Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer

    through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  • Compare rate of new onset or worsening therapy- induced peripheral neuropathy (TIPN) between Black patients and White patients with advanced cancer prospectively exposed to a taxane

    through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

Secondary Outcomes (10)

  • Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry)

    From baseline to end of treatment (i.e. up to 2 years)

  • Assess the significance of key attributes (tumor genomics, clinical demographics, SDoH, access, and the intersection of tumor biology and drug impact) on efficacy, and survival outcomes

    Baseline

  • Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy

    through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  • Assess the impact of toxicity as measured by dose reductions or dose cessations attributed to TIPN from chart review measured as RDI, a function of the ratio of received to intended doses, and thus accounts for differences in drugs or time of therapy

    through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  • Evaluate for differences in the impact of neuropathy between Black and White cancer patients on change in patient-reported QoL

    through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years

  • +5 more secondary outcomes

Study Arms (2)

Black patients with advanced cancer

Behavioral: Social Determinants of Health and toxicity questionnaires

Non Black patients with advanced cancer

Behavioral: Social Determinants of Health and toxicity questionnaires

Interventions

Social Determinants of Health and toxicity questionnairesBEHAVIORAL

Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.

Black patients with advanced cancerNon Black patients with advanced cancer

Eligibility Criteria

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

Those with cancers being referred for molecular testing through their site's precision genomics program.

You may qualify if:

  • Ability to provide written informed consent and HIPAA authorization
  • Patients must be ≥ 18 years old at the time of consent
  • Patients planning to undergo molecular testing as part of their routine cancer care

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood will be collected for a research grade genome wide association scan using Illumina's Ex Platform to determine ancestry

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Social Determinants of Health

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health StatusDemographyPopulation CharacteristicsHealth

Study Officials

  • Bryan P Schneider, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria McQuade, BA

CONTACT

(317) 278-5238mcquadem@iu.edu

Bryan P Schneider, MD

CONTACT

317-948-3855bpschnei@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine

Study Record Dates

First Submitted

August 23, 2023

First Posted

October 13, 2023

Study Start

January 26, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations

US(1)