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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03160768
Other study ID # HPP21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2017
Est. completion date May 2, 2019

Study information

Verified date May 2019
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

At St. Jude Children's Research Hospital, survivors who meet the eligibility criteria will be identified from SJLIFE protocol participants. After signing consent, the subject will have a blood specimen collected at the same time as the blood draw for the SJLIFE protocol. These samples will have T cell isolation performed then placed on ice and stored until batch shipment for investigation of p16 expression.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date May 2, 2019
Est. primary completion date May 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- Inability or refusal to give consent.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (2)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital HealthSpan Dx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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