- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04143048
A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules
8 maja 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Nieznany
Interwencja / Leczenie
- Inny: DNA extraction of tumer tissue samples and high-throughput sequencing of small panels
- Inny: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
- Inny: DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
Typ studiów
Obserwacyjny
Zapisy (Oczekiwany)
300
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Jiangsu
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Nanjing, Jiangsu, Chiny, 210029
- Rekrutacyjny
- First Affiliated Hospital of Nanjing Medical University
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Kontakt:
- Xiqiao none Zhou, doctor
- Numer telefonu: 13951826318
- E-mail: Xiqiao_zhou@126.com
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
Gastrointestinal stromal tumor patients in Jiangsu Provincial People's Hospital
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 września 2019
Zakończenie podstawowe (Oczekiwany)
31 maja 2020
Ukończenie studiów (Oczekiwany)
31 maja 2020
Daty rejestracji na studia
Pierwszy przesłany
18 października 2019
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 października 2019
Pierwszy wysłany (Rzeczywisty)
29 października 2019
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 maja 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 maja 2020
Ostatnia weryfikacja
1 maja 2020
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2019-SR-358
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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