Cancer Stem Cell Specific Aptamer's Ability to Detect Blood Circulating Cancer Stem Cells and Its Role as a Predictor of Prognosis in Pancreatic Cancer

Pancreatic Neoplasm Clinical Trial

Official title:

Cancer Stem Cell Specific Aptamer's Ability to Detect Blood Circulating Cancer Stem Cells and Its Role as a Predictor of Prognosis in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745415
• Other study ID #: 4-2017-1161
• Status: Completed
• Start date: March 29, 2018
• Est. completion date: March 29, 2021

Study information

• Verified date: February 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The treatment performance of pancreatic cancer has not changed significantly over the past 20 years and is still less than 10%. In addition, 80-90% of pancreatic cancer patients are found to be already advanced at the time of diagnosis, and it is the best malignant tumor in the human body with a 5-year survival rate of less than 10% and a median survival period of less than 1 year. However, early diagnosis of pancreatic cancer is still difficult, and there is no effective treatment other than surgery, so the increase in long-term survival rate over the past 20 years has been insignificant or stagnant. The response rate to anticancer drug treatment after surgery or anticancer drug when surgery is not possible is only around 20%, so it is very urgent to discover new biomarkers in predicting drug resistance and recurrence after surgery and predicting prognosis in advance. Minimally non-invasive diagnostic techniques are very important to detect and track cancer progression in the clinic. In particular, histological diagnosis and analysis have limitations in carcinomas, such as pancreatic cancer, which are small and distant, making it difficult to obtain tissue samples. CA 19-9, a prognostic marker for existing pancreatic cancer, 1) has low specificity for early diagnosis of pancreas, 2) is not detected in lewis A, B antibody-negative patients, and 3) shows false positive in cases with cholangitis at the same time. Because it has many disadvantages, the development of prognostic biomarkers in blood is urgently needed.

Recently, a study has been reported that the presence or absence of detection of circulating tumor cells is directly related to the prognosis of pancreatic cancer patients, and can be used for monitoring the patient's treatment response and for recurrence after surgery. In particular, the process of cancer metastasis consists of epithelial-to-mesenchymal transition and migration of cancer cells into the blood, and the existence of cancer stem cells is very important for metastasis and drug treatment resistance. Eventually, it is known to cause pancreatic cancer metastasis and recurrence.

Cancer stem cells have the ability to self-renew, the capability of developing, multiple cell lineages, and the potential of extensive proliferation, and the ability to detect cancer stem cells in the blood is important in pancreatic cancer patients who are at high risk of metastasis and recurrence. It is a non-invasive screening tool. Comparatively evaluate the treatment response and prognosis of pancreatic cancer patients according to the characteristics and subtypes of circulating cancer cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Men and women over 20 years of age

• Patients diagnosed with pancreatic cancer histologically or radiologically

Exclusion Criteria:

• non-pancreatic cancer

• Patients who failed to obtain informed consent from the patient

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Progression free survival : The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse	the duration from treatment initiation to disease progression (Up to 100 weeks)
Secondary	Overall survival	Overall survival : The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.	he duration from diagnosis of pancreatic cancer to death or last follow-up (up to 100 weeks)