ctDNA Screening in Advanced HER2 Positive Gastric Cancer

NCT04520295 | Unknown DMC

• 1 other identifier: BSctDNA-GC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.

Conditions

HER2-positive Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in molecular biomarkers at time on best overall response

  Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file.

  36 months

Secondary Outcomes (1)

• Change from baseline in molecular biomarkers at time on disease progression

  36 months

Study Arms (1)

HER2 positive cohort

Genetic: ctDNA screening

Interventions

ctDNA screening GENETIC

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.

HER2 positive cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HER2 positive gastric cancer patients

You may qualify if:

• Male/female patients aged over 18 years.
• Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
• 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.
• At least one measurable lesion should be confirmed by imaging examination.
• Eligible peripheral blood samples
• Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.
• For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.
• For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.
• Willing to provide clinicopathological information and imaging information.

You may not qualify if:

• Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
• With second primary malignant diseases.
• Other situations assessed by investigator can disturb quality control of the investigation.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Study Officials

• Jun Zhang

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liu

CONTACT

+86-18001753364; liujing23@vip.163.com

Chenfei Zhou

CONTACT

+86-13761618390; raining_grayday@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Oncology

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 20, 2020
• Study Start: May 19, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2025
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)