Inflammatory Myofibroblatic TumorNCT04572594
Molecular Profiling and Molecular Labeling of Inflammatory Myofibroblastic Tumor
An observational study of Inflammatory Myofibroblatic Tumor, run by Sun Yat-sen University at 1 site in China.
Trial summary
Gene mutation is a research hotspot in the occurrence of multiple malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Myofibroblatic Tumor
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: From December 2009 to July 2019, the histopathological diagnosis of inflammatory myofibroblastic tumor was confirmed by surgery or puncture at Sun Yat-sen University Cancer Center.
Who may be able to join
- From December 2009 to July 2019, patients who were pathologically diagnosed with inflammatory myofibroblastic tumor by Sun Yat-sen University Cancer Center；
- There are related pathological tissue wax blocks in Sun Yat-sen University Cancer Center;
- Patient clinical and prognosis tracking data are available.
Who cannot join
- The patient who has a clinically detectable second primary malignant tumor.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer center of SunYat-sen University
Guangzhou, Guangdong, 510060
Dongsheng Zhang, MD,PhD
Yan Wang, M.M., 86-2087343795, wangyan4@sysucc.org.cn
About this study
Official title: Study on the Molecular Profile and Molecular Signature of Inflammatory Myofibroblastic Tumor
Gene mutation is a research hotspot in the occurrence of multiple malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Large-scale gene profiling studies performed by humans in various types of epithelial tumors have confirmed some new gene mutations. However, there are few reports on the detection of genes related to inflammatory myofibroblastic tumor, and humans have not yet understood its molecular content. Therefore, it is necessary to further use molecular detection methods to explore the molecular markers of IMT to facilitate its follow-up precise treatment plan.
Read the detailed description
Inflammatory myofibroblastic tumor（IMT）is a rare clinical mesenchymal tissue-derived tumor, which can occur in almost all organs and soft tissues, and is characterized by low-grade or borderline tumors.
The diagnosis of inflammatory myofibroblastic tumor is mainly based on histopathology and immunohistochemistry. The treatment is resistant to conventional chemotherapy and radiotherapy. The only curative treatment is complete surgical resection. When IMT shows typical cellular structural features in pathology, the diagnosis is relatively simple. However, in the presence of atypical features, the accurate diagnosis of IMT is still a challenge. Therefore, it is necessary to explore a better diagnostic method. Secondly, there is no individualized treatment method for aggressive IMT patients who relapse and metastasize after surgery. At present, gene mutation is a research hotspot in the occurrence of various malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Large-scale gene profiling studies performed by humans in various types of epithelial tumors have confirmed some new gene mutations. However, there are few reports on the detection of inflammatory myofibroblastic tumor, and humans have not yet understood its molecular content. Therefore, it is necessary to further use molecular detection methods to explore the molecular markers of IMT to facilitate its follow-up precise treatment plan.
- Conditions
- Inflammatory Myofibroblatic Tumor
- Keywords
- IMT, gene, molecular profiling and molecular markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory myofibroblastic tumor | tissue of Inflammatory myofibroblastic tumor lession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing gene mutation spectrum of patients with inflammatory myofibroblastic tumor
We sequenced the genes in tissue samples from patients with inflammatory myofibroblastic tumor, and then analyzed the data to obtain a gene map of this type of tumor, and provide data support for the diagnosis and treatment of the disease.
Measured: through study completion，an average of 1 year
Secondary outcomes (1)
Exploring molecular markers for inflammatory myofibroblastic tumor
We sequenced tissue samples from patients with inflammatory myofibroblastic tumor, and then analyzed the data to explore molecular markers of this type of tumor, and provide assistance in the diagnosis and targeted therapy of the disease.
Measured: through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Myofibroblatic TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong sheng Zhang, Sun Yat-sen University
- Investigators
- Dongsheng Zhang, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572594
- Sponsor's protocol ID
- Molecular profiling of IMT
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 1 Oct 2020
- 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 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Molecular Profile and Molecular Signature of Inflammatory Myofibroblastic Tumor
- ClinicalTrials.gov ID
- NCT04572594
- Acronym / sponsor ID
- Molecular profiling of IMT
- Conditions
- Inflammatory Myofibroblatic Tumor
- Keywords
- IMT, gene, molecular profiling and molecular markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 1 Oct 2020 (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.
Gene mutation is a research hotspot in the occurrence of multiple malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Large-scale gene profiling studies performed by humans in various types of epithelial tumors have confirmed some new gene mutations. However, there are few reports on the detection of genes related to inflammatory myofibroblastic tumor, and humans have not yet understood its molecular content. Therefore, it is necessary to further use molecular detection methods to explore the molecular markers of IMT to facilitate its follow-up precise treatment plan.
Detailed description
Inflammatory myofibroblastic tumor（IMT）is a rare clinical mesenchymal tissue-derived tumor, which can occur in almost all organs and soft tissues, and is characterized by low-grade or borderline tumors.
The diagnosis of inflammatory myofibroblastic tumor is mainly based on histopathology and immunohistochemistry. The treatment is resistant to conventional chemotherapy and radiotherapy. The only curative treatment is complete surgical resection. When IMT shows typical cellular structural features in pathology, the diagnosis is relatively simple. However, in the presence of atypical features, the accurate diagnosis of IMT is still a challenge. Therefore, it is necessary to explore a better diagnostic method. Secondly, there is no individualized treatment method for aggressive IMT patients who relapse and metastasize after surgery. At present, gene mutation is a research hotspot in the occurrence of various malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Large-scale gene profiling studies performed by humans in various types of epithelial tumors have confirmed some new gene mutations. However, there are few reports on the detection of inflammatory myofibroblastic tumor, and humans have not yet understood its molecular content. Therefore, it is necessary to further use molecular detection methods to explore the molecular markers of IMT to facilitate its follow-up precise treatment plan.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory myofibroblastic tumor | – | –tissue of Inflammatory myofibroblastic tumor lession |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- From December 2009 to July 2019, the histopathological diagnosis of inflammatory myofibroblastic tumor was confirmed by surgery or puncture at Sun Yat-sen University Cancer Center.
Key inclusion criteria (3 listed)
- From December 2009 to July 2019, patients who were pathologically diagnosed with inflammatory myofibroblastic tumor by Sun Yat-sen University Cancer Center；
- There are related pathological tissue wax blocks in Sun Yat-sen University Cancer Center;
- Patient clinical and prognosis tracking data are available.
Key exclusion criteria (1 listed)
- The patient who has a clinically detectable second primary malignant tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishing gene mutation spectrum of patients with inflammatory myofibroblastic tumor
Time frame: through study completion，an average of 1 year
We sequenced the genes in tissue samples from patients with inflammatory myofibroblastic tumor, and then analyzed the data to obtain a gene map of this type of tumor, and provide data support for the diagnosis and treatment of the disease.
1 secondary outcome
Exploring molecular markers for inflammatory myofibroblastic tumor
Time frame: through study completion，an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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. This study is not recruiting at the moment.
Dongsheng Zhang, PhD principal investigator
Sun Yat-sen University
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 Inflammatory Myofibroblatic Tumor, run by Sun Yat-sen 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 1 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: status not confirmed, as of the sponsor's last update on 1 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongsheng Zhang, PhD (86-2087343795, zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing gene mutation spectrum of patients with inflammatory myofibroblastic tumor (time frame: through study completion，an average of 1 year). 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 1 Oct 2020.