Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06874283

Registry and Biobank of Patients With a History of Cancer Therapy to Study Ocular Complications

Led by University of Maryland, Baltimore ยท Updated on 2026-03-05

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients who have undergone cancer therapy to better understand eye problems that may arise from such treatments, including graft versus host disease (GVHD) and corneal toxicity. The study aims to collect detailed information and biological samples to investigate the immune and cellular changes related to these ocular complications. Patients with a history of cancer treatment and control participants without such history will be compared to identify factors predicting eye issues after cancer therapy. Participants will receive a standard eye exam as part of their routine care. Those in the cancer therapy group will also have biological samples collected, such as tears, cells from the eye surface, and blood, which will be stored and analyzed to study disease mechanisms. The study involves two groups: cancer therapy patients and controls without cancer therapy history. During the study, participants will provide their medical and eye history, undergo clinical evaluations, and have biological specimens collected. The primary outcome measured is the severity of chronic ocular GVHD, assessed at the time of the eye exam, typically between 3 months and up to 10 years after transplant, with an average around 3 years post-transplant. Data collection will continue until April 2031, with all procedures performed during routine ophthalmology visits.

CONDITIONS

Brief Title

Ocular Complications From Cancer Therapy - Patient Registry and Biobank

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • No history of eye diseases except cataract, glaucoma, mild dry eye, or history of cataract or refractive surgery
  • For cancer therapy group: history of allogenic hematopoietic stem cell transplant or prior cancer therapy including bone marrow transplant, chemotherapy, or immunotherapy
  • Recruited after cancer therapy or transplant at ophthalmology appointment
  • Able to understand and sign informed consent
  • For control group: no history of cancer or cancer therapy
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Neonates, children, prisoners, or institutionalized individuals
  • Unable or unwilling to provide informed consent
  • History of ocular surgery or eye disease except for refractive or cataract surgery, mild dry eye disease, or glaucoma
  • For control group: any history of cancer or cancer therapy including chemotherapy, immunotherapy, or bone marrow transplant

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At a single time point between 3 months to 10 years post cancer therapy or transplant

Participants undergo an eye exam and relevant clinical evaluations. Those in the cancer therapy group will also provide biological samples such as tear collection, impression cytology, and blood to study immunologic and molecular changes related to ocular complications.

1 visit (in-person)

Long-term Monitoring

Duration - Up to several years post eye exam

Participants are observed over time to evaluate ocular complications following cancer therapy or routine eye care in the control group.

Follow-up visits as part of routine care

Trial Site Locations

Total: 1 location

1

Stoler Outpatient Cancer Center at the University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

S

Sarah Sunshine, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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