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Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules

Primary Purpose

Advanced Colorectal Cancer, Circulating Tumor DNA

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Local treatment
Sponsored by
Junjie Peng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Colorectal Cancer focused on measuring advanced colorectal cancer, lung metastasis, circulating tumor DNA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 and ≤80 years old, regardless of gender;
  2. Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;
  3. Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;
  4. Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;
  5. For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);
  6. Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2;
  7. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;
  8. Surgical specimens or puncture specimens containing tumor tissue are available;
  9. 20 mL of peripheral blood are available (10 mL per tube, two tubes in total);
  10. Agreed to follow up for at least 2 years.

Exclusion Criteria:

  1. The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;
  2. Patients with stage I-III colorectal cancer;
  3. Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;
  4. Presence of metastasis other than lung;
  5. Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;
  6. Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;
  7. History of alcoholism or drug abuse;
  8. Pregnant or lactating patients.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive

Cohort 1-Arm B: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA negative

Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive

Cohort 2-Arm D: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA negative

Arm Description

ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA will be detected after curative treatment and then every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.

Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.

ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA is rechecked following treatment. Subjects with ctDNA positive after treatment will receive chemotherapy. Subjects with ctDNA negative after curative treatment will undergo routine follow-up. After treatment, ctDNA will be detected every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.

Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies

Secondary Outcome Measures

ctDNA positive rate in colorectal cancer patients with metastatic small pulmonary nodules
ctDNA positive prediction rate (Consistent with histopathological result as the standard for comparison)
The ctDNA clearance rate after local treatment
The ctDNA clearance rate after chemotherapy in patients achieving NED (Cohort 2)

Full Information

First Posted
July 26, 2022
Last Updated
August 8, 2022
Sponsor
Junjie Peng
Collaborators
Shanghai OrigiMed Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05495672
Brief Title
Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules
Official Title
Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Junjie Peng
Collaborators
Shanghai OrigiMed Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer, Circulating Tumor DNA
Keywords
advanced colorectal cancer, lung metastasis, circulating tumor DNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive
Arm Type
Experimental
Arm Description
ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA will be detected after curative treatment and then every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.
Arm Title
Cohort 1-Arm B: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA negative
Arm Type
No Intervention
Arm Description
Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.
Arm Title
Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive
Arm Type
Experimental
Arm Description
ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA is rechecked following treatment. Subjects with ctDNA positive after treatment will receive chemotherapy. Subjects with ctDNA negative after curative treatment will undergo routine follow-up. After treatment, ctDNA will be detected every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.
Arm Title
Cohort 2-Arm D: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA negative
Arm Type
No Intervention
Arm Description
Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.
Intervention Type
Procedure
Intervention Name(s)
Local treatment
Intervention Description
Radical surgical resection, local radiotherapy, radiofrequency ablation (RFA) or interventional therapy (absolute alcohol or cryotherapy). The equipment used for RFA of lung lesions consisted of the radiofrequency generator (CelonLab POWER), cold circulation pump (Celon Aquaflow Ⅲ), radiofrequency needle electrode (Celon proSurge: T20, T30 and T40 is an electrode length of 20, 30 and 40 mm respectively, and maximum output power of 20, 30 and 40 W; Olympus Surgical Technologies Europe, Hamburg, Germany).
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies
Time Frame
From date of treatment until the date of first documented progression or date of death from any cause, assessed up to 36 months.
Secondary Outcome Measure Information:
Title
ctDNA positive rate in colorectal cancer patients with metastatic small pulmonary nodules
Time Frame
4 weeks
Title
ctDNA positive prediction rate (Consistent with histopathological result as the standard for comparison)
Time Frame
8 weeks
Title
The ctDNA clearance rate after local treatment
Time Frame
8 weeks
Title
The ctDNA clearance rate after chemotherapy in patients achieving NED (Cohort 2)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤80 years old, regardless of gender; Pathologically confirmed as adenocarcinoma of advanced colorectal cancer; Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer; Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm; For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy); Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2; The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study; Surgical specimens or puncture specimens containing tumor tissue are available; 20 mL of peripheral blood are available (10 mL per tube, two tubes in total); Agreed to follow up for at least 2 years. Exclusion Criteria: The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions; Patients with stage I-III colorectal cancer; Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation; Presence of metastasis other than lung; Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function; Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus; History of alcoholism or drug abuse; Pregnant or lactating patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junjie Peng, MD, PhD
Phone
86-18017317122
Email
pengjj67@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhua Li, MD, PhD
Phone
13817922257
Email
whliiris@hotmail.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules

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