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OpenTrials
Active, not recruiting

NCT Number: NCT06002828

Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors

This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma or leukemia. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma or leukemia may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

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About this study

PRIMARY OBJECTIVE:

I. To evaluate the impact of social-environmental risk factors on changes in Charlson Comorbidity Index over time for adolescent and young adult cancer survivors.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo collection of blood samples on study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must be >= 18 years of age at the time of registration
  • Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL) or leukemia (acute lymphoblastic leukemia [ALL] only)
  • Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration
  • Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia (ALL) must have been within 3 years prior to registration
  • NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
  • Patient must be English speaking in order to be able to complete the required QOL forms on this study
  • NOTE: Sites cannot translate the associated QOL forms
  • Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma or leukemia
  • Patient must have internet access through computer, tablet, or smartphone
  • Patient must have email address
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Impact of social-environmental risk factors on changes in Charlson Comorbidity Index (CCI)

    Time frame: Through Study Completion, up to 2 years.

    Will fit Conway-Maxwell-Poisson mixed effects models with a log link to evaluate the impact of social-environmental risk factors on changes in CCI over time. Estimates will be reported as rate ratios (and 95% confidence intervals) on the link scale, with model-based marginal means by visit to aid interpretation on the count scale. Models will be fit by maximum likelihood using all observed visits; targeted diagnostics will assess dispersion, fit, and influence.

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Cancer Survivors

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Sep 15, 2026

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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