Immune Profiling for Cancer Immunotherapy Response

NCT ID: NCT06116032

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2029-01-01

Brief Summary

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In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.

Detailed Description

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Conditions

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Cancer Tumor, Solid Hematologic Malignancy Blood Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard of Care Checkpoint

Patients receiving standard of care FDA approved immunotherapy

Methylation Cytometry

Intervention Type DIAGNOSTIC_TEST

Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.

Bone Marrow Transplant

Patients undergoing transplant for hematologic malignancy

Methylation Cytometry

Intervention Type DIAGNOSTIC_TEST

Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.

CAR T

Patients undergoing CAR T therapy

Methylation Cytometry

Intervention Type DIAGNOSTIC_TEST

Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.

Interventions

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Methylation Cytometry

Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).
* Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).

Exclusion Criteria

* Pregnant women/fetuses/neonates
* Prisoners
* Decision-impaired individuals
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brock C. Christensen

Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brock C Christensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brock C Christensen, PhD

Role: CONTACT

603-650-1827

Hannah G Stolrow, BA

Role: CONTACT

7205174950

Facility Contacts

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Hannah G Stolrow, BA

Role: primary

7205174950

Other Identifiers

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Study02001227

Identifier Type: -

Identifier Source: org_study_id