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Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Liquid Biopsy MRD

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ClinicalTrials.gov Identifier: NCT05408897
Recruitment Status : Recruiting
First Posted : June 7, 2022
Last Update Posted : September 21, 2022
Information provided by (Responsible Party):
YE Yingjiang, Peking University People's Hospital

Brief Summary:
So far, MRD assessment by liquid biopsy (ctDNA) has not been used to predict postoperative treatment efficacy and recurrence risk of GIST patients because of special disease characteristics and technological limitations. Therefore, we conducted this prospective multi-center, single-arm observational study to collect 45 operable patients with locally advanced, suspected high-risk GIST. NGS genetic testing platform is used to detect tumour tissues and peripheral ctDNA will also be dectected. we try to explore the correlation between PFS/OS and MRD in high-risk GIST patients by analyzing the relationship between dynamic changes in ctDNA mutation spectrum and postoperative adjuvant therapy efficacy, and to evaluate MRD-based genomic characteristics to guide further treatment.

Condition or disease Intervention/treatment
Gastrointestinal Stromal Tumors Minimal Residual Disease Diagnostic Test: liquid biopsy

Detailed Description:

Assessing MRD (Minimal Residual Disease) and predicting the postoperative adjuvant treatment efficacy and recurrence risk of tumor patients based on ctDNA (circulating tumor DNA) detected by liquid biopsy have been exploratorily studied and applied in many types of cancers. However, as for GISTs (gastrointestinal stromal tumors), the most common mesenchymal neoplasm of the gastrointestinal tract, they have less peripheral ctDNA fragments compared with those tumors of hematological or epithelial origins. Since there are also some limitations of previous detection technology and detection depth, prospective study for prediction of postoperative treatment efficacy and recurrence risk of high-risk GIST is lacking.

In this study, a prospective multi-center, single-arm observational study is conducted to collect operable patients with locally advanced GIST. According to results of preoperative imaging examinations or pathological biopsy, 45 high-risk GIST patients will be screened and enrolled. Next-Generation Sequencing (NGS) genetic testing platform (Burning Rock Oncoscreen Plus TM) is used to detect the baseline tumour tissues (detection depth 1000X) of these patients. And peripheral ctDNA (detection depth 30000X) of multiple pre/postoperative time points will be detected. The genetic profile and clinical information of each patient will be collected. Combining all the information, bioinformatics analysis will be carried out on the gene detection results of these patients at each time point, and the correlation between the postoperative recurrence time and the ctDNA positive rate/postoperative clearance rate of patients will be compared. The characteristics changes and dynamic changes of tumor release degree will also be analyzed. To explore the correlation between PFS/OS and MRD in high-risk GIST patients, we plan to analyze the relationship between dynamic changes in ctDNA mutation spectrum and postoperative adjuvant therapy efficacy, and to evaluate MRD-based genomic characteristics to guide further treatment.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Minimal Residual Disease Detected by Liquid Biopsy
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Intervention Details:
  • Diagnostic Test: liquid biopsy
    A test that enables the diagnosis or analysis of tumors using only a blood or fluid sample rather than a solid tissue biopsy.

Primary Outcome Measures :
  1. recurrence [ Time Frame: 3 to 5 years ]
    Recurrence or metastasis of high-risk GIST after surgical resection followed by targeted drug therapy

Biospecimen Retention:   Samples With DNA

tumor tissues: collected from preoperative needle biopsy or specimens of surgical resection

blood tissues: venous blood collected at specific time point stipulated in the protocol

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study plans to invite patients with the following criteria: patients with resectable locally advanced GIST who received or did not receive neoadjuvant molecular targeted therapy, and patients with high recurrence risk grading by postoperative pathological assessment, including but not limited to the following clinical factors: Tumor Location, size, degree of mitoses, degree of tumor rupture, etc. Those who did not reach R0 resection or did not match the pathological staging, or who could not complete the test items required by the trial within the specified time due to the patient's non-cooperation, or who were deemed unsuitable by other investigators, would not be invited to participate in this study.

Inclusion Criteria:

  • Patients aged between 18 and 80
  • Patients suspected for high-risk GIST by preoperative imaging examinations or diagnosed with high-risk GIST by pathological biopsy, who have not received preoperative neoadjuvant treatment
  • Patients must have not received any treatment including radiotherapy, chemotherapy or surgery
  • The function of other organs including liver and kidneys is good enough so that the patients could tolerate targeted therapy and surgery
  • Postoperative pathology conformed the diagnosis of high-risk GIST
  • Patients and their families could understand the protocol of this study and voluntarily agree to participate in. Signed informed consents are required

Exclusion Criteria:

  • Previous medical history of malignant tumors or synchronous other malignancies
  • Emergent surgery because of bowel obstruction, perforation or bleeding
  • Pregnant or lactant women
  • Medical history of severe mental illness
  • Patients with contraindication for targeted therapy and surgery
  • Non-R0 resection
  • Postoperative pathology conformed the diagnosis of non-high-risk GIST
  • Patients with distant metastasis
  • Other situations in which researchers consider that the patient is unsuitable for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05408897

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China, Beijing
Peking University People'S Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Shuya Yang    15210226300    15210226300@163.com   
Sponsors and Collaborators
Peking University People's Hospital
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Principal Investigator: Yingjiang Ye Peking University People's Hospital
Publications of Results:
Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364. Erratum In: Nature. 2017 Dec 20;:

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Responsible Party: YE Yingjiang, Director of the department of gastrointestinal surgery, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05408897    
Other Study ID Numbers: WCJZL202103
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasm, Residual
Disease Attributes
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplastic Processes