Tools to evaluate treatment tolerability in older patients with sarcoma
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-007945
Sponsor Protocol Number: 21-007945
About this study
Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated with poor outcomes in sarcoma, as well as circulating senescence-associated secretory phenotype (SASP) proteins, which are associated with frailty.
This prospective, observational pilot study will examine factors which may affect tolerability of systemic therapy (chemotherapy, immunotherapy, and targeted therapy) in older patients with sarcoma. The study will combine clinical and laboratory monitoring of older patients (age 65 and above). Data (including screening tools and laboratory studies) will be collected at two timepoints – when patient consents to study and at the subsequent clinic visit with imaging assessment. Review of electronic medical record will be performed to evaluate clinically significant outcomes such as adverse events, hospitalizations, as well as treatment changes (delay or dose reductions) or discontinuation.
We hypothesize that clinical screening tools and laboratory tests can help evaluate older patients (age 65 years and above) with advanced/metastatic sarcoma who may develop toxicity with therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults age 65 and above.
- Men and women.
- Sarcoma diagnosis.
Exclusion Criteria:
Eligibility last updated 8/20/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Thanh Ho, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available