Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project

MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project (Deciphering Immunopathogenesis of MUCORmycosis to ADVANCE Risk Stratification, Diagnosis and Management of the Disease)

To collect data and samples from participants with cancer who also have invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection.

Study Overview

• Status: Not yet recruiting
• Conditions: Mucormycosis
• Intervention / Treatment: Behavioral: Mucormycosis

Detailed Description

Primary Objective:

To establish MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project.

• To prospectively identify, collect, and store all isolates causing proven or probable MCM in adult high-risk cancer participants.
• To prospectively identify, collect, and store relevant host samples from high-risk participants developing proven or probable MCM, along with relevant biospecimens from three control groups.
• To comprehensively annotate clinical specimens and provide information regarding the course and outcome of all MCM cases and controls.

OUTLINE:

This is an observational study. Patients are assigned to 1 of 4 groups.

GROUP M: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP A: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP B: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

GROUP C: Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dimitrios Kontoyiannis, MD; Phone Number: (713) 792-0826; Email: dkontoyi@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
      • Contact: Dimitrios Kontoyiannis, MD; Phone Number: 713-792-0826; Email: dkontoyi@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria:

• Patients must be 18-100 years old and have cancer and invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection but no evidence of such infection.
• Patients must be willing to undergo routine diagnostic procedures (e.g., phlebotomy, bronchoscopy, biopsy) as part of their regular care.

Exclusion Criteria:

• Patients who are unwilling to undergo routine diagnostic procedures as part of their regular care.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group M; Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.	Behavioral: Mucormycosis; Tell the study team about any symptoms or side effects you have, follow study directions, and come to all study appointments (or contact the study team to reschedule).
Group A; Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.	Behavioral: Mucormycosis; Tell the study team about any symptoms or side effects you have, follow study directions, and come to all study appointments (or contact the study team to reschedule).
Group B; Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.	Behavioral: Mucormycosis; Tell the study team about any symptoms or side effects you have, follow study directions, and come to all study appointments (or contact the study team to reschedule).
Group C; Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.	Behavioral: Mucormycosis; Tell the study team about any symptoms or side effects you have, follow study directions, and come to all study appointments (or contact the study team to reschedule).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Dimitrios Kontoyiannis, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Zygomycosis; Mucormycosis
• Other Study ID Numbers: 2024-1965; NCI-2025-01921 (Other Identifier: NCI -CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No