ctDNA Screening in Advanced HER2 Positive Gastric Cancer
NCT ID: NCT04520295
Last Updated: 2020-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-05-19
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HER2 positive cohort
ctDNA screening
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.
Interventions
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ctDNA screening
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive, HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
4. At least one measurable lesion should be confirmed by imaging examination.
5. Eligible peripheral blood samples
6. Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.
7. For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.
8. For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.
9. Willing to provide clinicopathological information and imaging information.
Exclusion Criteria
2. With second primary malignant diseases.
3. Other situations assessed by investigator can disturb quality control of the investigation.
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Jun Zhang
Chair of Department of Oncology
Principal Investigators
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Jun Zhang
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Department of Oncology, Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BSctDNA-GC
Identifier Type: -
Identifier Source: org_study_id
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