NCT03764371

Effects of Different Genetic Mutations on Prognosis in sMPLC Adenocarcinoma Patients

Status unknown Last updated 14 October 2021

What this trial tests

trial testing KAPA Hyper Prep Kit + Agilent SureSelectQXT in Gene Mutation in 20 participants. Status unknown.

Timeline

22 April 2019

Primary endpoint
30 August 2022

30 March 2024

Quick facts

Lead sponsor	The First Hospital of Jilin University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	20
Start date	22 April 2019
Primary completion	30 August 2022
Estimated completion	30 March 2024
Sites	1 location across China

Drugs / interventions tested

• KAPA Hyper Prep Kit + Agilent SureSelectQXT

Conditions studied

• Gene Mutation — all drugs for Gene Mutation →

Sponsor

The First Hospital of Jilin University

Who can join

Adults 18 to 75, any sex, with Gene Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the diagnostic criteria of sMPLC （synchronous multiple primary lung cancers）, and the diagnostic criteria of Martini and Melamed were extended and developed, Summarized as: (1) different histological types, different genetic characteristics, or different origin of carcinoma in situ; (2) the histological type is the same, the tumor is located in different lung or different lung lobes, the common lymphatic drainage site of lung cancer is not cancerous, and there is no extrapulmonary metastasis at the time of diagnosis.

Postoperative staging of each tumor was carried out in sMPLC patients, if all of them were stage I lung adenocarcinoma, whether adjuvant therapy could fully refer to the treatment principle of stage I NSCLC was considered, whether the benefit of subsequent application of adjuvant chemotherapy was still unclear, and whether adjuvant therapy was needed or not has been determined.

High-throughput sequencing, also known as "Next generation" sequencing (NGS), is characterized by sequencing of hundreds of thousands to millions of DNA molecules in parallel, and generally shorter reads.For multiple tumor lesions resected by sMPLC, only biopsy gene information from a single cancer focus may not be enough to identify all active driver gene mutations from the tumor. Therefore, NGS sequencing was proposed for all cancer lesions of sMPLC patients to reflect the full picture of gene mutation in such patients.

The investigators initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of NGS technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.