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Completed

NCT Number: NCT03160768

Feasibility of Isolating P16 Expression

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.

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Key information

Conditions

Childhood Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Within 3 months of enrollment of the last participant

    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.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • Sapere Bio

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 19, 2017
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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