Hairy Cell Leukemia Patient Data Registry

NCT02560883 | Recruiting

• 1 other identifier: OSU-12194
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 6

Brief Summary

The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 1,000 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends in outcomes, recognize the most effective treatments, discover previously unknown complications of the disease, and design clinical trials for new therapies.

Conditions

Leukemia, Other

Keywords

Hairy Cell

Outcome Measures

Primary Outcomes (1)

• Surveillance

  Establish a database of Hairy Cell Leukemia patients diagnosed or living in US to track Hairy Cell Leukemia disease course, patient reported outcomes, morbidity, and patient survival.

  up to 25 years

Secondary Outcomes (1)

• Research

  up to 25 years

Other Outcomes (1)

• Contact

  up to 25 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be a multi-institutional, international project that will collate clinical information from patients with Hairy Cell Leukemia from participating institutions in the Hairy Cell Leukemia Foundation. Patients within the United States with HCL, who live in remote areas, without access to a HCLFCenter of Excellence, may voluntarily submit their name and contact information, through the Hairy Cell Leukemia Foundation website.

You may qualify if:

• Patients with classic hairy cell leukemia
• Patients with the variant of hairy cell leukemia.

You may not qualify if:

• Children are excluded from the study, since Hairy Cell Leukemia wasn't described in children.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Hairy Cell Leukemia Foundation: collaborator

Study Sites (6)

University of Miami/Soffer Clinical Research Center

Miami, Florida, 33136, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Rochester /Wilmot Cancer Institute

Rochester, New York, 14642, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Peter MacCallum Cancer Center

Melbourne, Victoria, VIC 3000, Australia

RECRUITING

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

Related Links

• Hairy Cell Leukemia Foundation

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Michael Grever, MD

  The Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hairy Cell Leukemia Research Data Registry

CONTACT

614-685-4296; HCLRegistry@osumc.edu

Derick Campbell

CONTACT

614-366-5196

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 25, 2015
• Study Start: January 2, 2013
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

US (4); AU (1); CA (1)