Feasibility of Isolating P16 Expression

NCT03160768 | Completed

• 1 other identifier: HPP21
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Expression of the cell cycle regulator p16INK4a increases with age and toxic stressors. In mice, both radiation and chemotherapy are known to increase p16. Due to its influence on age-related regenerative capacity, p16 is an excellent candidate biomarker of physiologic reserve that may identify patients able to withstand the stressor of chemotherapy (low p16) from those unlikely to tolerate chemotherapy (high p16). That is, expression of p16 may predict physiologic, rather than chronologic, age. Such findings could have implications for care of cancer survivors and treatment decision-making in cancer patients. STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer during childhood.

Conditions

Childhood Cancer

Keywords

p16; T cell isolation; physiologic age

Outcome Measures

Primary Outcomes (1)

• Number of samples with successful isolation of expression of p16INK4a in CD3+ T lymphocytes

  Blood samples will be drawn once at a regularly scheduled follow-up visit. After T cells are isolated, the samples will be sent in one batch for further processing and investigation of p16 expression.

  Within 3 months of enrollment of the last participant

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

Participants will be childhood cancer survivors enrolled in the long-term follow-up study at St. Jude Children's Research Hospital.

You may qualify if:

• Enrolled in the SJLIFE study at St. Jude children's Research Hospital.
• Survivor of childhood cancer.
• Is 18 years of age and older.
• No evidence of cancer recurrence.
• Received prior chemotherapy (prior radiotherapy is allowed).

You may not qualify if:

• Inability or refusal to give consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Sapere Bio: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude Children's Research Hospital

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kirsten K. Ness, PT, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: May 25, 2017
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)