The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With FlapNCT02661776
The Change of NK Cell Activity After Head and Neck Cancer Surgery
An observational study of The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap, run by Yonsei University at 1 site in South Korea.
Trial summary
Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2016to 4 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing head and neck surgery
Who may be able to join
- 1) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap
Who cannot join
- patients refusal
- patients not able to read, or understand the consent form
- History of Active viral or bacterial infection
- History of use of immunosuppressive drugs within the last six months
- History of chemotherapy
- History of autoimmune disorders
Show all 9Show fewer
- Known HIV, Hepatitis B, or Hepatitis C infection
- Female who is pregnant, nursing
- ethnicity, other than asian
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.
- Conditions
- The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap
- Keywords
- natural killer cell, head and neck cancer, opioid
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of NK cell activity
Preoperative NK cell activity will be measured using the NK vue diagnostic test before surgery and anesthesia. Postoperative NK cell activity will be measured using the NK vue diagnostic test after 24 hours since stopping the use of intravenous remifentanil as analgesics during anesthesia in the operating room or sedation in the intensive care unit.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start24 Mar 2016
- Primary completion4 May 2017
- Study completion4 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With FlapStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661776
- Sponsor's protocol ID
- 4-2015-0987
- Status last verified
- Sep 2017
- First submitted
- 19 Jan 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share IPD
Publications
Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.
PubMed 24561245
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of NK Cell Activity After Head and Neck Cancer Surgery
- ClinicalTrials.gov ID
- NCT02661776
- Acronym / sponsor ID
- 4-2015-0987
- Conditions
- The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap
- Keywords
- natural killer cell, head and neck cancer, opioid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing head and neck surgery
Key inclusion criteria (1 listed)
- 1) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap
Key exclusion criteria (9 listed)
- patients refusal
- patients not able to read, or understand the consent form
- History of Active viral or bacterial infection
- History of use of immunosuppressive drugs within the last six months
- History of chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of NK cell activity
Time frame: 24 hours
Preoperative NK cell activity will be measured using the NK vue diagnostic test before surgery and anesthesia. Postoperative NK cell activity will be measured using the NK vue diagnostic test after 24 hours since stopping the use of intravenous remifentanil as analgesics during anesthesia in the operating room or sedation in the intensive care unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Background: PubMed 24561245Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.
- Individual participant dataSharing planned: No. no plan to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of NK cell activity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.