Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease

NCT01988701 | Withdrawn DMC

• 2 other identifiers: OSU-12208NCI-2013-01641
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.

Conditions

Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer

Keywords

GVHD; chronic Graft versus Host Disease

Outcome Measures

Primary Outcomes (1)

• Subsets and activation status of B, T, and NK lymphocytes

  Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.

  Up to 2 months

Secondary Outcomes (4)

• Logistical challenges with obtaining and processing samples in each of the subgroups of interest

  Up to 2 months

• Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD

  Up to 2 months

• Differences in cytokines in patients with cGVHD vs. those without

  Up to 2 months

• Differences in in lymphocyte activation between those with vs. without cGVHD

  Up to 2 months

Study Arms (2)

Allogeneic SCT Groups

Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic GVHD.

Other: Ancillary-Correlative

Autologous SCT group

Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment.

Other: Ancillary-Correlative

Interventions

Ancillary-Correlative OTHER

Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.

Also known as: Correlatives studies, laboratory biomarker analysis

Allogeneic SCT Groups; Autologous SCT group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received an autologous stem cell transplant and stem cell transplant at The Ohio State University.

You may qualify if:

• Allogeneic SCT groups: Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic graft-versus-host disease (GVHD)
• Autologous SCT group: Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Graft vs Host Disease; Hematologic Neoplasms; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Samantha Jaglowski, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Last Updated: March 2, 2015

Record last verified: 2015-02