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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT05745415
Collaborator
(none)
40
1
36
1.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Mar 29, 2018
    Actual Primary Completion Date :
    Mar 29, 2021
    Actual Study Completion Date :
    Mar 29, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    pancreatic cancer patients

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [the duration from treatment initiation to disease progression (Up to 100 weeks)]

      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

    Secondary Outcome Measures

    1. Overall survival [he duration from diagnosis of pancreatic cancer to death or last follow-up (up to 100 weeks)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Si Young Song, Severance Hospital, Yonsei University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05745415
    Other Study ID Numbers:
    • 4-2017-1161
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 27, 2023