Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

NCT ID: NCT02856646

Last Updated: 2021-12-15

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

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-07

Study Completion Date

2020-09-30

Brief Summary

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The purpose of this study is to gather data on patients diagnosed with and treated for classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is rendered, as well as assess the outcome of those treatment options and their impact on quality of life. Additional analyses will also attempt to identify prognostic or predictive biomarkers

Detailed Description

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Conditions

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Hodgkin's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Population with Condition

Community Sample

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
* Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
* Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
* Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
* Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
* Patients must consent for use of their FFPE tissue blocks for exploratory analyses

Exclusion Criteria

* Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
* Patients with unknown date of diagnosis of cHL
* Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
* Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
* Patients participating in a clinical study that does not allow enrollment into a non-interventional study
* Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-655

Identifier Type: -

Identifier Source: org_study_id