Fatty Acid Binding Proteins and Markers of Cellular Senescence in Cancer Survivors

NCT07114614 | Not Yet Recruiting DMC

• 1 other identifier: CASE5Z25
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to investigate whether cancer survivors have higher levels of proteins called Fatty Acid Binding Proteins as well as 12 different markers of cellular senescence than people who have never had cancer. Investigators believe that these levels may be elevated in cancer survivors as a result of their cancer and the treatments they received and may put them at higher risk for chronic conditions such as high cholesterol, diabetes, high blood pressure, and obesity. This study will also compare the levels of these proteins and inflammatory markers in the blood with different aspects of cancer treatment the survivors received. Investigators are investigating if there is a correlation between levels of these proteins and markers, the type of treatment cancer survivors received, and development of metabolic conditions.

Conditions

Marker; Structural

Keywords

Fatty Acid Binding Proteins; Cancer Survivors; FABP4 and FABP5

Outcome Measures

Primary Outcomes (2)

• Correlation between FABP levels and the development of risk factors for metabolic syndrome and inflammation

  Baseline

• To determine the correlation with types of cancer-directed therapy received.

  Baseline

Study Arms (2)

Cancer participants

Other: Specimen #1; Other: Specimen #2

Control Group

Other: Specimen #1; Other: Specimen #2

Interventions

Specimen #1 OTHER

Specimen 1 will be collected in a 10 ml SST (serum separator tube).

Cancer participants; Control Group

Specimen #2 OTHER

Specimen #2 will be collected in a 10 ml SST (serum separator tube)

Cancer participants; Control Group

Eligibility Criteria

• Age: 5 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

For pediatric control participants, labs will be drawn with IV placement prior to procedure or sedation. Measurements will be taken during the same visit. If desired by patient and parent, a separate research visit can be arranged for participants to have labs drawn at their convenience. For adult control participants, a research visit will be arranged at the participants' convenience for measurements to be obtained and study labs to be drawn.

You may qualify if:

• Diagnosis of at least one malignancy for which chemotherapy, radiation, and/or stem cell transplantation was utilized as part of treatment
• Completed all therapeutic interventions for their malignancy and are at least 2 years off therapy
• At least 1-year post-stem cell transplant for malignant condition

You may not qualify if:

• Pregnancy at the time of the study
• Any autoimmune condition including but not limited to lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis, type 1 diabetes, EXCEPT well-controlled autoimmune hypothyroidism for at least 6 months
• Presence of active graft versus host disease
• Malignancy treated using surgery only
• Acute relapsed disease or second malignancy
• Transplant for non-malignant conditions (e.g. cell disease, Hurler syndrome)
• Currently taking systemic steroids and/or immunosuppressant medications
• Acute illness necessitating hospitalization in the 30 days prior to blood draw
• Presence of a chronic inflammatory disease EXCEPT obesity
• Fever, active infection or inflammation, or taking antibiotics at the time of blood draw
• A diagnosis of Type 2 diabetes or Hypertension treated with medication
• Currently lipid lowering medications
• Growth hormone deficiency or hypothalamic dysfunction

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, UH Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Central Study Contacts

Hackney Lisa, MD

CONTACT

216-541-1088; Lisa.hackney@uhhospitals.org

Study Design

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

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)