Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262386
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-09-22
Brief Title:
Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Utilizing Perioperative Variation Trends of Circulating Tumor Cells and Tumor Pathological Characteristics as a Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2023-08
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:
For patients with lung cancer who have undergone tumor resection early relapse significantly impacts survival However there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse To address this clinical challenge many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse Despite these efforts we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates
In our preliminary analysis of previous study data we observed that patients with a smaller reduction in circulating tumor cells CTCs within the first three days after surgery followed by an increase on the third-day post-operation are more likely to experience early relapse during regular monitoring This pattern may be indicative of minimal residual disease By combining trends in circulating tumor cell variations with pathologic characteristics we aim to select patients for adjuvant therapy who are at high risk of developing early relapse
The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases
In our preliminary analysis of previous study data we observed that patients with a smaller reduction in circulating tumor cells CTCs within the first three days after surgery followed by an increase on the third-day post-operation are more likely to experience early relapse during regular monitoring This pattern may be indicative of minimal residual disease By combining trends in circulating tumor cell variations with pathologic characteristics we aim to select patients for adjuvant therapy who are at high risk of developing early relapse
The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases
Detailed Description:
For patients with resectable lung cancer anatomic resection alongside mediastinal lymph node dissection is pivotal in removing all tumor tissue visible on imaging from the patients body Despite these efforts early relapse remains a significant issue Literature review shows that the early relapse rate varies between 8 to 10 potentially due to undetectable occult metastasis by imaging modalities suggesting the presence of minimal residual disease or tumor cells evading the primary site Limitations in imaging such as the slice thickness in computed tomography CT scans which range from 0375 to 05 centimeters can render tumors smaller than the slice thickness invisible Similarly tumors smaller than 05 cm may not accumulate sufficient F18-Deoxyglucose to be detectable in positron emission tomography PET scans Additionally tumor cells may migrate to extrapulmonary sites via lymphatic drainage or circulation
Survival studies have predominantly focused on the pathologic TNM stage which aggregates different disease presentations with similar survival outcomes However the heterogeneity inherent in pathology may help in identifying patients prone to relapse From a tumor biology perspective tumor cells may detach from surrounding tissues becoming more invasive and entering the bloodstream Circulating tumor cells CTCs have been recognized early in cancer stages and are correlated with treatment response tumor genetic alterations and survival Research has combined CT tumor size and CTCs in a malignancy prediction model for suspicious pulmonary lesions highlighting that CTCs can rebound in patients experiencing early relapse indicating occult metastases or minimal residual disease
Systemic adjuvant therapy is considered the best approach to minimize disease relapse in resectable lung cancer patients Although many studies have sought to identify patients at risk of relapse to improve survival the presence of intrapulmonary N1 or mediastinal N2 lymph node invasion significantly affects survival in non-small cell lung cancer patients Even tumors smaller than 1 cm carry a risk of lymph node metastases with respective risks for cT1a cT1b and cT1c tumors reported as 38 163 and 196 Therefore patients with tumors larger than 1 cm are recommended adjuvant therapy due to the high risk of lymph node involvement Adjuvant chemotherapy is advised for patients with stages 1b to 3a showing a 54 survival benefit by the fifth postoperative year although this benefit diminishes in subsequent years This could be due to adjuvant therapy being administered based on the pathologic stage rather than the likelihood of relapse Tumor heterogeneity might also influence the response to different therapeutic regimens Molecular profiling of tumors has identified mutations predicting responses to targeted therapies and elucidated drug resistance mechanisms offering more precise treatments and improving survival Targeted and immune therapies have shown improved survival in specific tumor subgroups
This study aims to utilize trends in CTC variations as a screening tool to identify patients at risk of relapse and prescribe adjuvant therapy to evaluate the therapeutic efficacy and survival impact of CTCs
Survival studies have predominantly focused on the pathologic TNM stage which aggregates different disease presentations with similar survival outcomes However the heterogeneity inherent in pathology may help in identifying patients prone to relapse From a tumor biology perspective tumor cells may detach from surrounding tissues becoming more invasive and entering the bloodstream Circulating tumor cells CTCs have been recognized early in cancer stages and are correlated with treatment response tumor genetic alterations and survival Research has combined CT tumor size and CTCs in a malignancy prediction model for suspicious pulmonary lesions highlighting that CTCs can rebound in patients experiencing early relapse indicating occult metastases or minimal residual disease
Systemic adjuvant therapy is considered the best approach to minimize disease relapse in resectable lung cancer patients Although many studies have sought to identify patients at risk of relapse to improve survival the presence of intrapulmonary N1 or mediastinal N2 lymph node invasion significantly affects survival in non-small cell lung cancer patients Even tumors smaller than 1 cm carry a risk of lymph node metastases with respective risks for cT1a cT1b and cT1c tumors reported as 38 163 and 196 Therefore patients with tumors larger than 1 cm are recommended adjuvant therapy due to the high risk of lymph node involvement Adjuvant chemotherapy is advised for patients with stages 1b to 3a showing a 54 survival benefit by the fifth postoperative year although this benefit diminishes in subsequent years This could be due to adjuvant therapy being administered based on the pathologic stage rather than the likelihood of relapse Tumor heterogeneity might also influence the response to different therapeutic regimens Molecular profiling of tumors has identified mutations predicting responses to targeted therapies and elucidated drug resistance mechanisms offering more precise treatments and improving survival Targeted and immune therapies have shown improved survival in specific tumor subgroups
This study aims to utilize trends in CTC variations as a screening tool to identify patients at risk of relapse and prescribe adjuvant therapy to evaluate the therapeutic efficacy and survival impact of CTCs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None