Hematological MalignanciesNCT07763184
mNGS for IFD in Patients With Hematological Malignancies
An observational study of Hematological Malignancies and Invasive Fungal Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematological Malignancies, Invasive Fungal Disease
- What is being tested?
- metagenomic next-generation sequencing
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population for this research consists of patients with hematological malignancies who are suspected of having IFD.
Who may be able to join
- Voluntarily signed the Informed Consent Form (ICF);
- Diagnosed with a hematological malignancy and receiving necessary treatment according to clinical medical orders;
- Presenting with clinical symptoms, signs, or imaging features suspected of IFD. Clinical symptoms or signs include fever, cough, expectoration, chest pain, skin and soft tissue infectious lesions, or symptoms related to other deep tissue involvement. Imaging features vary depending on the site of infection, including: if involving the lower respiratory tract/lungs, a CT scan showing at least the presence of dense, well-defined lesions (with or without a halo sign), air crescent sign, cavity, wedge-shaped/segmental or lobar consolidations, reversed halo sign, etc.; if involving the central nervous system (CNS), an MRI/CT scan indicating meningeal enhancement; or corresponding imaging features for the involvement of other deep tissues.
Who cannot join
- Unable to undergo necessary conventional microbiological testing or imaging examinations;
- Deemed unsuitable to participate in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Ren Lin, +86-20-61641615, lansinglinren@163.com
About this study
Official title: Application of Peripheral Blood Pathogen Metagenomic Next-Generation Sequencing in the Diagnosis of Invasive Fungal Disease in Patients With Hematological Malignancies
Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Due to the suppression of immune system function during the disease and its treatment process, patients with hematological malignancies are prone to opportunistic infections, including IFD, with the lungs being the most common site of infection. In patients with hematological malignancies, IFD is often difficult to diagnose and progresses rapidly. Some patients become critically ill, which severely affects their prognosis. With the rapid development of molecular biology techniques, metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms-as a broad-coverage, highly sensitive diagnostic tool with a short reporting cycle-has been widely applied in the etiological diagnosis of clinical infectious diseases. However, its clinical value in the diagnosis of IFD remains to be explored. This study is a single-center, single-arm, open-label clinical study to to explore the clinical performance of peripheral blood mNGS in the diagnosis and treatment of IFD in patients with hematological malignancies.
- Being tested
- metagenomic next-generation sequencing
- Medical subject headings
- Hematologic Neoplasms, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metagenomic next-generation sequencingDiagnostic test
The peripheral blood of the anticipants will be collected and sent to Tianjin Concord Bojing Medical Diagnostic Technology Co., Ltd. for mNGS testing.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hematological malignancies who are suspected of having IFD | Not described Receives: Diagnostic Test: metagenomic next-generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of peripheral blood mNGS in diagnosing IFD
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763184
- Sponsor's protocol ID
- NFEC-2026-512
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Peripheral Blood Pathogen Metagenomic Next-Generation Sequencing in the Diagnosis of Invasive Fungal Disease in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07763184
- Acronym / sponsor ID
- NFEC-2026-512
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Due to the suppression of immune system function during the disease and its treatment process, patients with hematological malignancies are prone to opportunistic infections, including IFD, with the lungs being the most common site of infection. In patients with hematological malignancies, IFD is often difficult to diagnose and progresses rapidly. Some patients become critically ill, which severely affects their prognosis. With the rapid development of molecular biology techniques, metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms-as a broad-coverage, highly sensitive diagnostic tool with a short reporting cycle-has been widely applied in the etiological diagnosis of clinical infectious diseases. However, its clinical value in the diagnosis of IFD remains to be explored. This study is a single-center, single-arm, open-label clinical study to to explore the clinical performance of peripheral blood mNGS in the diagnosis and treatment of IFD in patients with hematological malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hematological malignancies who are suspected of having IFD | – | Diagnostic Test: metagenomic next-generation sequencing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this research consists of patients with hematological malignancies who are suspected of having IFD.
Key inclusion criteria (3 listed)
- Voluntarily signed the Informed Consent Form (ICF);
- Diagnosed with a hematological malignancy and receiving necessary treatment according to clinical medical orders;
- Presenting with clinical symptoms, signs, or imaging features suspected of IFD. Clinical symptoms or signs include fever, cough, expectoration, chest pain, skin and soft tissue infectious lesions, or symptoms related to other deep tissue involvement. Imaging features vary depending on the site of infection, including: if involving the lower respiratory tract/lungs, a CT scan showing at least the presence of dense, well-defined lesions (with or without a halo sign), air crescent sign, cavity, wedge-shaped/segmental or lobar consolidations, reversed halo sign, etc.; if involving the central nervous system (CNS), an MRI/CT scan indicating meningeal enhancement; or corresponding imaging features for the involvement of other deep tissues.
Key exclusion criteria (2 listed)
- Unable to undergo necessary conventional microbiological testing or imaging examinations;
- Deemed unsuitable to participate in this study by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metagenomic next-generation sequencingThe peripheral blood of the anticipants will be collected and sent to Tianjin Concord Bojing Medical Diagnostic Technology Co., Ltd. for mNGS testing. | Diagnostic test | Patients with hematological malignancies who are suspected of having IFD |
Primary outcome
The sensitivity and specificity of peripheral blood mNGS in diagnosing IFD
Time frame: up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for Hematological Malignancies
Active, not recruitingPhase 1
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Hematological Malignancies
Active, not recruitingPhase 1
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Hematological Malignancies
RecruitingPhase 2
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Hematological Malignancies
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies and Invasive Fungal Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ren Lin (+86-20-61641615, lansinglinren@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of peripheral blood mNGS in diagnosing IFD (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.