Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project

M.D. Anderson Cancer Center

Status: Not yet enrolling

Conditions: Mucormycosis

Treatments: Behavioral: Mucormycosis

Study type: Observational

Funder types: Other

Identifiers

NCT06878144

2024-1965

NCI-2025-01921 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 4 patient groups

Group M

Description:

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

Treatment:

Behavioral: Mucormycosis

Group A

Description:

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

Treatment:

Behavioral: Mucormycosis

Group B

Description:

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

Treatment:

Behavioral: Mucormycosis

Group C

Description:

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

Treatment:

Behavioral: Mucormycosis