A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules
8 mai 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
- Autre: DNA extraction of tumer tissue samples and high-throughput sequencing of small panels
- Autre: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
- Autre: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
Type d'étude
Observationnel
Inscription (Anticipé)
300
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Jiangsu
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Nanjing, Jiangsu, Chine, 210029
- Recrutement
- First Affiliated Hospital of Nanjing Medical University
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Contact:
- Xiqiao none Zhou, doctor
- Numéro de téléphone: 13951826318
- E-mail: Xiqiao_zhou@126.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Gastrointestinal stromal tumor patients in Jiangsu Provincial People's Hospital
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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).
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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
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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.
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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
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
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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.
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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
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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Délai: 2019.8-2019.10
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DNA extraction of tumer tissue samples ,Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing
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2019.8-2019.10
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Délai: 2019.11-2020.5
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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
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2019.11-2020.5
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2019
Achèvement primaire (Anticipé)
31 mai 2020
Achèvement de l'étude (Anticipé)
31 mai 2020
Dates d'inscription aux études
Première soumission
18 octobre 2019
Première soumission répondant aux critères de contrôle qualité
27 octobre 2019
Première publication (Réel)
29 octobre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mai 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2020
Dernière vérification
1 mai 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2019-SR-358
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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