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Not Yet Recruiting
NCT07743086
Impact of Duffy-null Associated Neutropenia on Chemotherapy Dosing
Conditions: Solid Tumor Cancer
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 886
Sponsor: Barbara Ann Karmanos Cancer Institute
Location: Karmanos Cancer Institute Detroit Michigan
Summary
The goal of this clinical trial is to:
* In Phase 1 (observational) to develop an algorithm for treatment of Duffy-null positive patients for chemotherapy dosing
* In Phase 2 (interventional), use the algorithm created in phase 1 to adjust chemotherapy dosing for Duffy-null patients
Eligibility Criteria
Inclusion Criteria:
* Participant must self-identify as being of Middle Eastern or African descent.
* Participant must be diagnosed with histologically or cytologically confirmed solid organ cancer and be treatment naive.
* Melanoma is allowed; sarcoma is not eligible.
* Secondary malignancies are allowed.
* Participants who have received only surgery alone as treatment are eligible
* Participant must be between the ages of 18-80.
* Participant or their legally authorized representative (LAR) must be able to understand a written informed consent document and be willing to sign it.
Exclusion Criteria:
* Participants with active and uncontrolled bacterial, viral, or fungal infection requiring IV antibiotics.
• Participants may be eligible for the study if the infection is deemed to be under control per investigator's discretion.
* Participants who have ever received cytotoxic chemotherapy.
• Those who have already started a chemotherapy regimen with moderate likelihood of developing neutropenia will be considered for enrollment at the principal investigator's discretion.
* Participants who are receiving concurrent chemo-radiation treatment.
* Participants who are taking any other investigational drugs.
* Participants who are pregnant or breastfeeding.
* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.
Source: ClinicalTrials.gov (NCT07743086). StuddyBuddy aggregates publicly available trial information.