A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules

May 8, 2020 updated by: The First Affiliated Hospital with Nanjing Medical University
Gastrointestinal Stromal Tumors (GIST) is the most common mesenchymal tumor of the gastrointestinal tract, and the incidence rate in China has increased year by year in recent years.Gastrointestinal stromal tumors are not sensitive to radiotherapy and traditional infusion chemotherapy. Currently, they are generally treated with surgery, but they are prone to recurrence and metastasis.For nodules with a particle size between 2 and 5 cm, there may be both benign and malignant, and there is still a lack of fast and accurate methods for distinguishing benign and malignant.Many benign nodules were removed (in the pathological examination of postoperative resected tissue). In addition, if it is found to be late, there is a possibility of invading surrounding tissues and metastasis, so that it is impossible to cure. Therefore, early diagnosis and early surgery and benign and malignant differentiation of small nodules are the key to the clinical diagnosis and treatment of gastrointestinal stromal tumors.At present, second-generation gene sequencing (NGS) and liquid biopsy are rarely reported in the field of GIST. A few domestic and foreign studies have found that it can detect rare mutation types, and may find secondary gene mutations early, which has potential applicability, but Overall, the clinical guidance of these NGS-based studies focuses on prognosis and drug resistance , as well as some studies based on low-throughput platforms. Therefore, early diagnosis and benign and malignant discrimination based on high-throughput sequencing and liquid biopsy have significant clinical significance for the diagnosis and treatment of gastrointestinal stromal tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Gastrointestinal stromal tumor patients in Jiangsu Provincial People's Hospital

Description

Inclusion Criteria:

  • Patients who are scheduled for stromal tumor resection
  • Signed informed consent

Exclusion Criteria:

  • the vital signs are not stable
  • unconscious
  • unwilling to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The construction of Gene detection technology flow
At this stage, a small panel targeted high-throughput sequencing process for gastrointestinal stromal tumors was established, and the association of tumor-associated mutation profiles in different patients with clinical stage was initially explored. It is planned to collect about 100 cases of gastrointestinal stromal tumors after surgery (freezing tissue or FFPE sections), DNA extraction and high-throughput sequencing of small panels, and analysis of the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging).
Other: DNA extraction of tumer tissue samples and high-throughput sequencing of small panels
DNA extraction of stromal tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed
Establishment of non-invasive gene testing technology process
In this stage, we plan to establish a small panel of peripheral blood cfDNA targeting high-throughput sequencing process, and verify the consistency of peripheral blood cfDNA and tissue gDNA in gene detection of gastrointestinal stromal tumors. About 50 patients were planned to be enrolled. Peripheral blood was collected once for each patient and the blood volume was 10mL. Meanwhile, the tumor tissue samples were collected within 5mm in diameter, depending on the size of the lesion . DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor.
Other: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor
Other: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
DNA extraction and small panel sequencing were conducted for each patient sample. Based on the indicator results of the previous mutant spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutant spectrum, and compared with the real clinical data of patients
Prospective cohort (double-blind recommended)
Peripheral blood of about 150 patients was collected once and the blood volume was 10mL . Meanwhile, the tumor tissue samples were collected within 5mm in diameter, depending on the size of the lesion. Patients focus on the early stage of stromal tumors or those whose size under gastroenteroscopy is between 2 and 5 cm. DNA extraction and small panel sequencing were conducted for each patient sample. Based on the indicator results of the previous mutation spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutation spectrum, and compared with the real clinical data of patients.
Other: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor
Other: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
DNA extraction and small panel sequencing were conducted for each patient sample. Based on the indicator results of the previous mutant spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutant spectrum, and compared with the real clinical data of patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Time Frame: 2019.8-2019.10
DNA extraction of tumer tissue samples ,Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing
2019.8-2019.10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Time Frame: 2019.11-2020.5
DNA extraction of tumer tissue samples and blood tissue .To evaluate the consistency of peripheral blood cfDNA and tissue gDNA in gene detection of gastrointestinal stromal tumors,Using mutational spectra to determine the clinical stage of the patient and the benign and malignant small nodules
2019.11-2020.5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-SR-358

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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