## Protocol Section
### Identification Module
**NCT ID:** NCT06422637

**Brief Title:** A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy

**Official Title:** INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy

#### Organization Study ID Info
**ID:** ES-2024-025-02
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital of Guangzhou Medical University
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The First Affiliated Hospital of Guangzhou Medical University

#### Responsible Party

**Investigator Affiliation:** The First Affiliated Hospital of Guangzhou Medical University

**Investigator Full Name:** Jianxing He

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). By using clinical pathology as the gold standard, it will parallelly compare the performance (with a sensitivity of ≥90%) of the MERCURY early lung cancer screening model against the LDCT-only screening group within the "Love Lung Project." Ultimately, the objective is to reduce the proportion of overtreatment, achieve earlier staging, and extend patient survival, thus enhancing clinical value.

**Detailed Description:** This study is the first international prospective interventional study for lung cancer screening. It designates the "Love Lung Program" using Low-Dose Computed Tomography (LDCT) screening as the control group and the MERCURY screening group as the intervention group. Participants from the general population were enrolled and randomly assigned to either group in a 1:1 ratio. The MERCURY group plans to collect baseline peripheral blood samples from 2,972 individuals for whole genome sequencing (WGS) based on plasma circulating free DNA (cfDNA). This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA. Through the MERCURY early lung cancer screening model, individuals potentially at early stages of lung cancer will be identified. Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status, eventually confirmed via surgery or pathology. To minimize ethical risks, the negative cases will receive additional LDCT after three months to further confirm their lung status. The control group under the "Love Lung Program" will follow standard LDCT screening procedures with the same number of participants; those with positive LDCT results will undergo clinical diagnosis, while those with negative results will only be followed up for lung status. Relying on the "Love Lung Program," the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics.

### Conditions Module

**Conditions:**

- Liquid Biopsy for Early Screening of Lung Cancer

**Keywords:**

- Lung Cancer

- Liquid Biopsy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 5944

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** By collecting 2,972 peripheral blood samples from a natural population baseline, a comprehensive analysis of the fragmentomic characteristics of cfDNA was conducted based on whole-genome sequencing (WGS) of plasma cfDNA.

**Intervention Names:**

- Diagnostic Test: Liquid Biopsy Early Screening

**Label:** Intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 2972 individuals were enrolled from the general population for routine LDCT screening.

**Label:** control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** An early screening model for lung cancer aids in identifying individuals with early-stage lung cancer. Those with positive indications of lung cancer will subsequently undergo confirmatory clinical assessments using Low-Dose Computed Tomography (LDCT) in sequence. Ultimately, a definitive diagnosis of lung cancer is established through surgical and pathological examination.

**Name:** Liquid Biopsy Early Screening

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** When a test result indicates that a patient is positive, the probability that the true condition is positive.

**Measure:** Positive Predictive Value

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** the proportion of patients diagnosed with lung cancer through clinical pathology in both the intervention group and the control group.

**Measure:** Detection rate of non-stage 0 lung cancer within 2 years

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age greater than 40 years old and less than 75 years old, regardless of gender.
* Sign the informed consent form.

Exclusion Criteria:

* Pregnant women;
* Individuals currently diagnosed with any tumors other than lung cancer, or who have a history of cancer;
* Those who have undergone LDCT/CT screening within the past 1-3 years;
* Individuals currently suffering from a febrile illness, or who have had an acute inflammatory disease episode requiring internal medicine treatment within the last 14 days prior to blood draw;
* Individuals who have taken corticosteroids orally or through intravenous injection within the 14 days prior to blood draw;
* Organ transplant recipients or those who have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant;
* Individuals in poor health or not suitable for blood drawing;
* Any other clinically significant disease or condition considered by the researchers to potentially affect adherence to the protocol, impact the patient's ability to provide informed consent, or render the patient unsuitable for participation in the clinical trial.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drjianxing.he@gmail.com

**Name:** Jianxing He, MD

**Phone:** 86-20-83337792

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

**State:** Guangdong

**Zip:** 510120

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital

**Name:** Jianxing He, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** publish an article

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
