Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773626
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-02-24
Brief Title:
Tumor Deposits in Cancer Colon
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Evaluation of the Role of Tumor Deposits on the Prognosis of Colorectal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
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:
1 Assessment of correlation between tumor deposits and clinicopathological characteristics of colorectal cancer
2 Detection of association between tumor deposits and stage of colorectal cancer
3 Evaluate the relationship between tumor deposits and prognosis of colorectal cancer patient
2 Detection of association between tumor deposits and stage of colorectal cancer
3 Evaluate the relationship between tumor deposits and prognosis of colorectal cancer patient
Detailed Description:
Colorectal cancer remains the third most common cancer and the third leading cause of cancer-related deaths For colon cancer alone 101220 new cases were projected to occur in 2019 causing51020 deaths
A number of risk factors have been identified that influence susceptibility to colorectal cancer including a family history the presence of adenomatous polyps inflammatory bowel disease ulcerative colitis or Crohns disease and number of environmental factors of which diet is the most significant
CRC differs from many other cancers in that diagnosis of the disease can be made earlier by screening techniques including colonoscopy The progression of CRC is well established and begins with hyperproliferation of the colonic mucosa and adenoma formation and then adenocarcinomas that vary in metastatic potential
The progression from normal intestinal epithelium to an invasive carcinoma is estimated to take 7-12 years With the advent of early screening measures developed over the last few decades CRC has become a preventable disease by treating patients with adenomatous polyps Nearly 50 of patients diagnosed with CRC develop metastasis within five years Most commonly these tumors metastasize to the liver and lungs but may be discovered in many other sites
Despite significant improvements in both prevention and screening over the last twenty years about 36500 36 of such cases are still being diagnosed in stage III with regional lymph node involvement LN N1a-b N2a-b or tumor deposits TD N1c
Tumor deposits TDs or mesenteric tumor satellites were firs described in rectal carcinoma by Gabriel et al at St Marks Hospital in 1935 Subsequently TDs have been detected in various malignancies other than colorectal carcinoma including gastric pancreatic gallbladder and bile duct carcinomas Over the years there is much debate about the genesis histopathologic characteristics and prognostic value of TDs
TDs are associated with advanced colorectal carcinoma stage and poor prognosis with variable outcome due to different definitions of TDs
Before the 5th edition published in 1997 TNM classification did not consider microscopic TDs to be lymph node metastases LNMs and they classified them as discontinuous extension in the T category
In the 5th TNM edition the 3-mm rule was introduced which stated that TDs 3mm in diameter were LNMs
In the 6th edition published in 2002 TDs were classified based on the contour of the deposit A TD with a smooth contour was considered as LMN whereas a TD with an irregular contour was considered as venous invasion V12 or lymphatic invasion L1
The 8th TNM Edition clarified that the presence of TDs does not change the primary tumor T category but changes the node status N to pN1c if all regional lymph nodes are negative on pathological examination
In studies of rectal cancer patients it should be taken into account that TDs may indicate microscopic residuals of the main tumor after neoadjuvant chemo radiation and not discontinuous foci of tumor as indicated in the classic definition of TDs
The presence of TDs was an independent adverse prognostic factor that was significantly associated with shorter disease-free survival independent of lymph node status in stage IV colorectal cancer patients who underwent simultaneous resection for synchronous colorectal liver metastases
After chemo-radiotherapy rectal cancer is usually associated with small clusters of tumor cells or isolated tumor cells scattered within or outside the rectal wall which are often associated to fibrosis and chronic inflammation as well as other radiation induced changes The prognostic significance of TDs in rectal adenocarcinoma following neoadjuvant chemoradiation has not yet been determined although this remains an important issue given that patients who receive neoadjuvant chemoradiation have more advanced tumors and the highest risk of distant and local recurrences
TDs were associated with higher rates of lymph node involvement distant metastases and reduced survival more over TDs are associated with aggressive characteristics including higher rates of positive circumferential resection margins
A number of risk factors have been identified that influence susceptibility to colorectal cancer including a family history the presence of adenomatous polyps inflammatory bowel disease ulcerative colitis or Crohns disease and number of environmental factors of which diet is the most significant
CRC differs from many other cancers in that diagnosis of the disease can be made earlier by screening techniques including colonoscopy The progression of CRC is well established and begins with hyperproliferation of the colonic mucosa and adenoma formation and then adenocarcinomas that vary in metastatic potential
The progression from normal intestinal epithelium to an invasive carcinoma is estimated to take 7-12 years With the advent of early screening measures developed over the last few decades CRC has become a preventable disease by treating patients with adenomatous polyps Nearly 50 of patients diagnosed with CRC develop metastasis within five years Most commonly these tumors metastasize to the liver and lungs but may be discovered in many other sites
Despite significant improvements in both prevention and screening over the last twenty years about 36500 36 of such cases are still being diagnosed in stage III with regional lymph node involvement LN N1a-b N2a-b or tumor deposits TD N1c
Tumor deposits TDs or mesenteric tumor satellites were firs described in rectal carcinoma by Gabriel et al at St Marks Hospital in 1935 Subsequently TDs have been detected in various malignancies other than colorectal carcinoma including gastric pancreatic gallbladder and bile duct carcinomas Over the years there is much debate about the genesis histopathologic characteristics and prognostic value of TDs
TDs are associated with advanced colorectal carcinoma stage and poor prognosis with variable outcome due to different definitions of TDs
Before the 5th edition published in 1997 TNM classification did not consider microscopic TDs to be lymph node metastases LNMs and they classified them as discontinuous extension in the T category
In the 5th TNM edition the 3-mm rule was introduced which stated that TDs 3mm in diameter were LNMs
In the 6th edition published in 2002 TDs were classified based on the contour of the deposit A TD with a smooth contour was considered as LMN whereas a TD with an irregular contour was considered as venous invasion V12 or lymphatic invasion L1
The 8th TNM Edition clarified that the presence of TDs does not change the primary tumor T category but changes the node status N to pN1c if all regional lymph nodes are negative on pathological examination
In studies of rectal cancer patients it should be taken into account that TDs may indicate microscopic residuals of the main tumor after neoadjuvant chemo radiation and not discontinuous foci of tumor as indicated in the classic definition of TDs
The presence of TDs was an independent adverse prognostic factor that was significantly associated with shorter disease-free survival independent of lymph node status in stage IV colorectal cancer patients who underwent simultaneous resection for synchronous colorectal liver metastases
After chemo-radiotherapy rectal cancer is usually associated with small clusters of tumor cells or isolated tumor cells scattered within or outside the rectal wall which are often associated to fibrosis and chronic inflammation as well as other radiation induced changes The prognostic significance of TDs in rectal adenocarcinoma following neoadjuvant chemoradiation has not yet been determined although this remains an important issue given that patients who receive neoadjuvant chemoradiation have more advanced tumors and the highest risk of distant and local recurrences
TDs were associated with higher rates of lymph node involvement distant metastases and reduced survival more over TDs are associated with aggressive characteristics including higher rates of positive circumferential resection margins
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