Telomere and Telomerase

NCT01176422 | Withdrawn

• 1 other identifier: 12016
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers hope to determine if the DNA is shortened in your body and determine if there is an increase in the protein that shortens DNA called telomerase.

Conditions

Acute Myeloid Leukemia

Keywords

AML; MDS

Outcome Measures

Primary Outcomes (1)

• Identification and resolution of telomere dysfunction-induced focus (TIF) and normalization of telomerase activity

  Advancing myelodysplasia is associated with progressive telomere attrition and clonal chromosomal evolution. Based on this hypothesis, we expect to see identification of TIF by immunostaining and increase in Telomerase activity in peripheral blood granulocytes of patients with advanced Myelodysplastic Syndrome (MDS) and acute myeloid leukemia. We also expect to see resolution of TIF and normalization of telomerase activity upon treatment.

  up to 24 weeks

Study Arms (1)

advanced Myelodysplastic Syndrome or acute myeloid leukemia

advanced MDS and AML with/without associated cytogenetic abnormality

Genetic: Blood sample

Interventions

Blood sample GENETIC

Blood samples will be collected before and after treatment completion.

advanced Myelodysplastic Syndrome or acute myeloid leukemia

Eligibility Criteria

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

Study Population

Patients will be selected from the BMT/Hematology clinic in the Cancer Center.

You may qualify if:

• Diagnosis of advanced Myelodysplastic Syndrome (MDS) or acute myeloid leukemia
• must be 18 years of age
• must be able to give written informed consent

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center, Westwood Campus

Westwood, Kansas, 66205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two teaspoons of blood will be collected - one teaspoon before subject begins treatment for disease and one teaspoon will be collected when subject completes treatment.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Siddhartha Ganguly, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 6, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (1)