IRB Study Number 21-797
Status Recruiting
Institutes Taussig Cancer Institute, Pediatric Institute
Description
Primary Aims
Aim 1: Determine if adult survivors of HCT have altered microbiome diversity compared to controls.
Aim 2: Determine if adult survivors of autologous HCT for lymphoma with insulin resistan
Aim 3: Determine if chronic graft-verus-host disease (cGVHD) impacts microbiome diversity in allogeneic HCT survivors. Determine if adult survivors of allogeneic HCT with insulin resistance have altered microbiome diversity compared to survivors without insulin resistance.
Secondary Aims
Aim 1: Among adult survivors of HCT, determine if microbiome diversity is associated with markers of chronic inflammation and dyslipidemia.
Aim 2: Among adult survivors of autologous HCT for lymphoma, explore the relationship between microbiome and a history of radiation exposure.
Aim 3: Among adult survivors of allogenic HCT explore the relationship between microbiome and a history of total body irradiation exposure.
Inclusion Criteria
3.2.1. BMT survivors:
Age ≥ 18 years at the time of HCT
Underwent autologous HCT for lymphoma (Cohort A) or Allogenic HCT (Cohort B) at Cleveland Clinic
Did not received a subsequent HCT or CAR-T cell therapy
≥2 years since HCT cell infusion
Remains in a complete remission
No oral or intravenous antibiotic use within the previous 6 months
Subjects must be willing to have fecal samples collected, dried blood spot specimen collected, medical history abstracted from the electronic medical record and willing to fill out a brief questionnaire
3.2.2. Controls:
Age ≥ 18 years
No history of blood and marrow transplantation
No history of chemotherapy or radiation
Off all immunosuppressive medications for ≥6 months
No oral or intravenous antibiotic use within the previous 6 months
Subjects must be willing to have fecal samples collected, dried blood spot specimen collected, medical history abstracted from the electronic medical record and willing to fill out a brief questionnaire
Exclusion Criteria
Age ≤18 years at the time of HCT
Underwent autologous HCT for lymphoma (Cohort A) or Allogenic HCT (Cohort B) outside of Cleveland Clinic
Received subsequent HCT or CAR-T cell therapy
≤2 years since HCT cell infusion
Current or newly diagnosed malignancy
Oral or intravenous antibiotic use within the previous 6 months
Subjects must is unwilling to have fecal samples collected, dried blood spot specimen collected, medical history abstracted from the electronic medical record and willing to fill out a brief questionnaire
Subjects not meeting all inclusion criteria, or
Subjects who refuse or are unable to sign informed consent form
