Ignite Creation Date:
2025-12-18 @ 8:36 AM
Ignite Modification Date:
2025-12-23 @ 10:30 PM
Study NCT ID:
NCT07001085
Status:
None
Last Update Posted:
2025-06-03 00:00:00
First Post:
2025-05-09 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ctDNA Monitoring in Patients With HCC and mCRC
Sponsor:
None
Organization:
Study Overview
Official Title:
A Prospective Randomized Trial Assessing the Impact of ctDNA Testing in Patients After Liver Resection or Transplantation Due to Metastases From Colorectal Cancer or Hepatocellular Carcinoma (HCC) on Treatment Strategies and Long-term Survival"
Status:
None
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Health problem Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is estimated that it accounts for 80-90% all cases of liver cancer. Liver cancer is one of the faster growing and worse prognosis cancers. It constitutes approximately 5.4% of all malignant tumors.
Colorectal cancer (CRC) is currently the third most common cancer in the world and in Poland. Every year in the Polish population about 20,000 people will be diagnosed with colorectal cancer. Most of them will be diagnosed in the advanced stage IV of the disease. About 50% of CRC patients will develop liver metastases during the natural course of disease progression. Surgery for liver metastases is the only potential treatment. Even after tumor resection surgery, the disease may continue to develop even if the patient is undergoing chemotherapy.
Furthermore, the accuracy and sensitivity of pathological and imaging methods for disease progression or molecular identification of residual disease (MRD) are limited, while when the specificity and clinical diagnostic utility of serum markers (CEA) is poor. CT/MRI/PET being part of the standard surveillance program increases ability to detect recurrences, but are not sensitive enough for small lesions, especially in patients after liver resection or modern chemotherapy, i.e. targeted therapy. Most patients have no measurable disease based on imaging until an obvious recurrence occurs. Often it is too late for any intervention. Each recurrence of the disease is also a failure of the chemotherapy. In addition, second line chemotherapy is less likely to work success in terms of long-term patient survival. Therefore, there is an urgent need to improve approaches to long-term non-invasive tumor monitoring and predict recurrence earlier than standard imaging, and to evaluate the effect of surgical intervention and chemotherapy, especially in stage IV cancer.
The awarding criterion - HCC is a rare disease. Awarding criterion - the area of surgery and diagnostics.
In the case of patients with colorectal cancer, the target group of patients to be included in the study are patients over 18 years of age with metastases of colorectal cancer. Colon limited to the liver, with no history of cancer other than colorectal cancer. The study will include synchronous and metachronous metastases according to: new definition.
In the case of hepatocellular carcinoma (HCC), the target group is patients with resectable HCC, in the case of liver resection or unresectable HCC in the case of liver transplantation. The study will include patients with or without cirrhosis. Qualification for liver transplantation and indication for transplantation liver disease will be taken into account, among others, using the French model of HCC (calculator), which takes into account the size and number of lesions and the AFP level.
Patients with or without cirrhosis will be qualified for liver resection. The group will include patients from the age of 18 to the age of 75 in the case resection and all patients qualified for liver transplantation at the liver transplantation qualification meeting.
Patients with completely removed primary tumor in the large intestine will be in the study group.
Chemotherapy is not an indication for the study. According to treatment standards, the vast majority of patients with colorectal cancer and/or metastases will undergo treatment chemotherapy. Currently, not enough scientific research has been conducted to determine how and whether chemotherapy administered to patients affects the results ctDNA. Additionally, the study assumes that patients will be covered by the standard of care in this group of patients.
Patients with extrahepatic lesions will not be included in the study. Patients with rapid disease progression on chemotherapy with a 6-month survival period uncertain will not be included in the research. Patients older than 75 years of age will also not be included in the study.
Patients undergoing steroid therapy and diagnosed with autoimmune diseases will not be included in the study.
The goal of surgical treatment is to achieve R0 resection of all liver metastases. Patients after liver resection with radiologically visible recurrence will undergo treatment further treatment according to the decision of the oncology team. Hepatic and extrahepatic recurrence does not exclude the patient from the study.
Detailed treatment protocol
1. Qualification of the patient for liver resection or transplantation. Assessment of patients at an oncology consultation.
2. Obtaining informed consent to participate in the study.
3. Randomization of patients in a 2:1 ratio by drawing a code indicating ctDNA testing (control group - without ctDNA testing)
3\. Assessment of the patient immediately before surgery.
a. Physical and subjective examination. i. Assessment of quality of life using the Polish version of the EORTC QLQ-C30 form b. Performing laboratory and imaging tests in accordance with local protocol. i. Biochemical tests ii. Imaging tests 4. Collecting 10ml of blood for gDNA and ctDNA testing along with routine preoperative blood collection.
5\. Surgery 6. Liver resection or orthotopic liver transplantation from a deceased donor. 8. Monitoring the patient in the surgical intensive care unit. 9. Monitoring the patient in the general room at the Department of General, Transplantation and Liver Surgery.
10\. Discharge of the patient home and completion of surgical treatment. 11. Monitoring the patient in the general room of the Hepatology Clinic in the case of transplantation or in the Polyclinic in the case of liver resection.
12\. Transplantation/surgical outpatient clinic: Assessment on the 30th day (with a deviation of 2-3 days) after surgery in terms of the occurrence of postoperative complications, assessment general examination of the patient and 2 taking a blood sample for ctDNA testing.
13\. Transplant/surgical outpatient clinic: Assessment in the 6th month (with a deviation of a few days) after surgery in terms of the patient's general condition and possible recurrence cancer process, taking a third blood sample for ctDNA testing. 14. Transplant/surgical outpatient clinic: Monitoring the cancer process and assessing patients one year after resection/transplantation.
16\. End of the observation period of patients 12 months after the last collection
Colorectal cancer (CRC) is currently the third most common cancer in the world and in Poland. Every year in the Polish population about 20,000 people will be diagnosed with colorectal cancer. Most of them will be diagnosed in the advanced stage IV of the disease. About 50% of CRC patients will develop liver metastases during the natural course of disease progression. Surgery for liver metastases is the only potential treatment. Even after tumor resection surgery, the disease may continue to develop even if the patient is undergoing chemotherapy.
Furthermore, the accuracy and sensitivity of pathological and imaging methods for disease progression or molecular identification of residual disease (MRD) are limited, while when the specificity and clinical diagnostic utility of serum markers (CEA) is poor. CT/MRI/PET being part of the standard surveillance program increases ability to detect recurrences, but are not sensitive enough for small lesions, especially in patients after liver resection or modern chemotherapy, i.e. targeted therapy. Most patients have no measurable disease based on imaging until an obvious recurrence occurs. Often it is too late for any intervention. Each recurrence of the disease is also a failure of the chemotherapy. In addition, second line chemotherapy is less likely to work success in terms of long-term patient survival. Therefore, there is an urgent need to improve approaches to long-term non-invasive tumor monitoring and predict recurrence earlier than standard imaging, and to evaluate the effect of surgical intervention and chemotherapy, especially in stage IV cancer.
The awarding criterion - HCC is a rare disease. Awarding criterion - the area of surgery and diagnostics.
In the case of patients with colorectal cancer, the target group of patients to be included in the study are patients over 18 years of age with metastases of colorectal cancer. Colon limited to the liver, with no history of cancer other than colorectal cancer. The study will include synchronous and metachronous metastases according to: new definition.
In the case of hepatocellular carcinoma (HCC), the target group is patients with resectable HCC, in the case of liver resection or unresectable HCC in the case of liver transplantation. The study will include patients with or without cirrhosis. Qualification for liver transplantation and indication for transplantation liver disease will be taken into account, among others, using the French model of HCC (calculator), which takes into account the size and number of lesions and the AFP level.
Patients with or without cirrhosis will be qualified for liver resection. The group will include patients from the age of 18 to the age of 75 in the case resection and all patients qualified for liver transplantation at the liver transplantation qualification meeting.
Patients with completely removed primary tumor in the large intestine will be in the study group.
Chemotherapy is not an indication for the study. According to treatment standards, the vast majority of patients with colorectal cancer and/or metastases will undergo treatment chemotherapy. Currently, not enough scientific research has been conducted to determine how and whether chemotherapy administered to patients affects the results ctDNA. Additionally, the study assumes that patients will be covered by the standard of care in this group of patients.
Patients with extrahepatic lesions will not be included in the study. Patients with rapid disease progression on chemotherapy with a 6-month survival period uncertain will not be included in the research. Patients older than 75 years of age will also not be included in the study.
Patients undergoing steroid therapy and diagnosed with autoimmune diseases will not be included in the study.
The goal of surgical treatment is to achieve R0 resection of all liver metastases. Patients after liver resection with radiologically visible recurrence will undergo treatment further treatment according to the decision of the oncology team. Hepatic and extrahepatic recurrence does not exclude the patient from the study.
Detailed treatment protocol
1. Qualification of the patient for liver resection or transplantation. Assessment of patients at an oncology consultation.
2. Obtaining informed consent to participate in the study.
3. Randomization of patients in a 2:1 ratio by drawing a code indicating ctDNA testing (control group - without ctDNA testing)
3\. Assessment of the patient immediately before surgery.
a. Physical and subjective examination. i. Assessment of quality of life using the Polish version of the EORTC QLQ-C30 form b. Performing laboratory and imaging tests in accordance with local protocol. i. Biochemical tests ii. Imaging tests 4. Collecting 10ml of blood for gDNA and ctDNA testing along with routine preoperative blood collection.
5\. Surgery 6. Liver resection or orthotopic liver transplantation from a deceased donor. 8. Monitoring the patient in the surgical intensive care unit. 9. Monitoring the patient in the general room at the Department of General, Transplantation and Liver Surgery.
10\. Discharge of the patient home and completion of surgical treatment. 11. Monitoring the patient in the general room of the Hepatology Clinic in the case of transplantation or in the Polyclinic in the case of liver resection.
12\. Transplantation/surgical outpatient clinic: Assessment on the 30th day (with a deviation of 2-3 days) after surgery in terms of the occurrence of postoperative complications, assessment general examination of the patient and 2 taking a blood sample for ctDNA testing.
13\. Transplant/surgical outpatient clinic: Assessment in the 6th month (with a deviation of a few days) after surgery in terms of the patient's general condition and possible recurrence cancer process, taking a third blood sample for ctDNA testing. 14. Transplant/surgical outpatient clinic: Monitoring the cancer process and assessing patients one year after resection/transplantation.
16\. End of the observation period of patients 12 months after the last collection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: