Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04958551 |
| Other study ID # |
IRB00006761-M2021180 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 10, 2021 |
| Est. completion date |
July 10, 2025 |
Study information
| Verified date |
January 2023 |
| Source |
Peking University Third Hospital |
| Contact |
Jia-kuo Yu, Phd. |
| Phone |
+86 13331031448 |
| Email |
yujiakuo[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Biological samples are important human genetic resources, which can provide great value for
medical research, and how to protect and rationally utilize them is of great
importance.However, at present, the blood samples after laboratory examination and the
damaged tissue cleaned up in the operation will be treated as medical waste and treated
according to the standard of medical waste.However, if these samples can be effectively
collected and reasonably used, they can provide extremely high value for the study of sports
injury-related diseases.Sports injury and joint structure belongs to multiple factors cause
abnormal, through the degenerative osteoarthritis, cruciate ligament injury, patellar
dislocation, discoid meniscus injury related basic research project establishment and collect
the founding the research institute of sports medicine treated patients with sports injury,
including degenerative osteoarthritis, intraoperative tissue, blood and saliva samples,To
sample from the micro level of susceptibility genes and molecular signaling pathways to
anatomical morphology and histopathologic study direction, and so on, can also for multiple
transverse comparison research between samples, in order to investigate sports injury,
including degenerative osteoarthritis pathogenesis, for sports trauma related disease
etiology, diagnosis, treatment to provide new ideas and methods,And the selection of
athletes, athletes special training plans, sports mode to provide more targeted
suggestions.This study strictly complied with the Regulations of the People's Republic of
China on the Management of Human Genetic Resources to establish the Institute of Sports
Medicine Sample Bank, which can reduce the waste of human genetic resources in China, promote
the development of the discipline, and provide a higher platform for the study of sports
injure-related diseases.
Description:
I. Research Background In the "Twelfth Five-Year Plan for Biotechnology Development", the
requirements for the construction of national biological science facilities are clearly put
forward, and the construction of a national biological center, which includes the biological
technology management information database and biological sample resource database.Biobank
mainly refers to the standardized collection, processing, storage and application of
biomacromolecules, cells, tissues and organs of healthy and disease organisms, including
human organ tissues, whole blood, plasma, serum, biological fluid or processed biological
samples (DNA, RNA, protein, etc.).Establish a standardized quality control, information
management and application system for samples 1.In 1987 the American Institute of Cancer
Research established a biobank of cancer samples.The UK Biobank was set up in 1999 to collect
and closely monitor samples from 500,000 volunteers.At the same time, domestic and foreign
research institutions are also jointly building and sharing biobanks.Europe, for example, has
carried out genetic studies involving 520,000 people in 23 sample centers in 10 European
countries.Human genetic resources are important strategic resources, China has a unique
advantage of human genetic resources, effective protection and rational use of human genetic
resources is very important.Proper collection of abundant and large sample resources is bound
to provide great value for biological and medical research 3.
Sports medicine institute, Peking University third hospital is the largest sports medicine
center, about 120000 m years MenZhenLiang, nearly 10000 years since, before the operation
exsanguinate assay blood samples in laboratory tests, after the completion of the operation
clean up the damage of tissue samples at the end of the surgery, for medical waste, by
medical waste treatment, but the samples has high research value.From including
morphological, genetic and molecular mechanism study 4-6, for sample tissue pathological
slices, gene sequencing and other research methods to the field of sports medicine related
diseases have a deeper understanding, and provide samples for future researchers reserve
platform, to build samples of sports medicine institute library.
Sports injuries and joint structural abnormalities are multi-factor causes. Through the
establishment of this project and the collection of intraoperative tissue, blood and saliva
samples from patients with sports injuries, including degenerative osteoarthritis, admitted
to the Institute of Sports Medicine of the Third Hospital of Beijing Medical University,To
sample from the micro level of susceptibility genes and molecular signaling pathways to
anatomical morphology and histopathologic study direction, and so on, can also for multiple
transverse comparison research between samples, in order to investigate sports injury,
including degenerative osteoarthritis pathogenesis, for sports trauma related disease
etiology, diagnosis, treatment to provide new ideas and methods,And the selection of
athletes, athletes special training plans, sports mode to provide more targeted suggestions.
II. Research Objectives
1. After the completion of the laboratory examination, the blood samples and tissue samples
and body fluids discarded during the operation are retained for the purpose of building
the "Basic Research Project on Sports Injuries Related to Degenerative Osteoarthritis,
Cruciate Ligament Injury, Patella Dislocation, Discoid Meniscus and so on".
2. Use the samples of "Basic Research Project on Sports Injury Related to Degenerative
Oosteoarthritis, Cruciate Ligament Injury, Patella Dislocation, Discoid Meniscus and
Other Sports Injury" to conduct related research on the mechanism of sports injury, new
treatment methods and treatment techniques to improve the efficacy.
III. Experimental design:
1. Biological sample collection 1.1 Target population of sample collection Outpatients,
inpatients, follow-up patients and third-class blood relatives or close relatives of patients
with degenerative osteoarthritis, cruciate ligament injury, patella dislocation, discoid
meniscus who were admitted to the Institute of Sports Medicine of the Third Hospital of
Peking University voluntarily enrolled in the biobase.
1.2 Sample collection and preservation
1. For patients undergoing sports injury surgery, intraoperative tissue stump (divided into
2 pieces) and remaining whole blood samples (1.5 mL/piece, a total of 3 pieces) were
mainly collected. Meanwhile, genetic information was extracted and preserved for some
samples.In strict accordance with the standardized operation process of project samples,
samples are processed and stored separately in the warehouse, and stored in the -80℃
ultra-low temperature refrigerator or -196℃ liquid nitrogen tank.Patient related imaging
and surgical data were recorded and saved by the hospital system.
2. The remaining whole blood samples (1.5 mL/piece, 3 pieces in total) and saliva samples
(about 3 mL/piece) were mainly collected from the other subjects except the patients
undergoing surgery. At the same time, genetic information of some samples was extracted
and stored.In strict accordance with the standardized operation process of project
samples, samples are processed and stored separately in the warehouse, and stored in the
-80℃ ultra-low temperature refrigerator or -196℃ liquid nitrogen tank.Relevant imaging
and surgical data were recorded from previous medical records or provided by the
subjects themselves.
2. Biobank preservation and management The biobank is in strict compliance with the
Regulations of the People's Republic of China on the Management of Human Genetic Resources
for sample storage, processing and management.
2.1 Quality control of sample warehousing In strict accordance with the standardized
operation process of project samples, samples are processed and stored separately in the
warehouse, and stored in the -80℃ ultra-low temperature refrigerator or -196℃ liquid nitrogen
tank.For genetic extraction of tissue samples, blood and saliva samples, ensure that the
total number of samples is at least 1ug, and ensure that the sample OD 260/280 is close to
2.0.
2.2 Sample information management The sample information was managed electronically by the
biobank information management system of Peking University Third Hospital.Keep full operation
records including sample processing, packing, warehousing, quality inspection, freeze-thaw,
loss reporting, etc., and relevant documents signed by the operator.
2.3 Safety of sample environment The environmental safety of samples is managed according to
the standard of the biobank of Peking University Third Hospital. Automatic monitoring system
of temperature, humidity and environment is adopted to collect and record the samples in real
time.In case of any abnormality, the system will inform the management staff of the biobank
of the Institute of Sports Medicine of our hospital through SMS.
2.4 Regular quality inspection of samples Quality tests were carried out according to the
standards of the biobank of Peking University Third Hospital. Quality tests of DNA, RNA,
tissue samples and cell activity were carried out regularly to ensure the accuracy of the
results obtained from the samples for subsequent studies.
3. Basic research related to biological samples The collected biological samples were
sequenced and analyzed for genetic information, tissue morphology, and expression
determination and analysis of related biomolecules.
Four, data management:
1. Data entry:
According to the original observation records of the subjects, the researchers will
timely, complete, correct and clear data into the case report form.After being reviewed
and signed by the principal investigator, the questionnaire should be sent to the
clinical study data administrator in a timely manner.
2. Contents and methods of data verification and management:
When all case report forms are checked without error, the data manager will write the
database inspection report, which includes the study completion status (including the
list of exclusions), inclusion/exclusion criteria, integrity check, logical consistency
check, outlier data check, time window check, adverse event check, etc.
At the audit meeting, the principal investigator, data administrator and statisticians
will make decisions on subjects' signing of informed consent and questions raised in the
database inspection report, and write the audit report. The database will be locked at
the same time.
3. Data archiving:
After data entry and verification as required, the case report form shall be archived in
numbered order and filled in with the retrieval directory for future reference.Electronic
data files, including databases, inspection procedures, analysis procedures, analysis
results, codebooks and explanatory files, should be classified and stored in multiple backups
on different disks or recording media. They should be properly stored to prevent damage.All
original files shall be kept for the specified period of time.
V. Safety evaluation:
There is no special risk associated with participation in this study.The sampling process of
tissue samples will not affect the quantity and quality of blood tests and examinations of
patients before surgery, nor will it affect the surgical method of patients, nor will it
affect the choice of surgical method by the surgeon. Therefore, there will be no change in
preoperative preparation, intraoperative operation and surgical effect, and there will be no
related risks.
Participation in this study will not increase any medical history and illness inquiries,
physical examination content, blood tests, auxiliary examinations such as X-ray, CT, MRI and
B-mode ultrasound, and will not increase any fees.
VI. Subject Protection (Informed Consent, Subject's Benefits and Risks, Confidentiality,
Conflict of Interest and Other Ethical Consideration) According to relevant Chinese laws and
regulations, before the start of the study, the researcher shall give written and oral
explanations to the subjects regarding the background, nature, significance, steps, benefits,
risks and withdrawal of the study, etc., and an informed consent signed by each subject (or
legal representative of the subject) shall be obtained.The informed consent form is dated and
its copy is kept separately by the investigator and the subject.
Seven, research management
1. Scheme modification (define the principle and process of scheme modification after the
project starts) It could be that the researchers found persistent non-compliance with
the inclusion criteria caused the change, or it could be that the inclusion criteria
were too strict and the number of recruits was too low.Revision of changes in this part
of the study protocol should take into account any statistical effects, such as
adjustment of sample size due to changes in event rates, or revision of the analysis
plan.
2. Quality management (project supervision plan) :
Specific monitoring contents include:
1. The verification scheme shall be submitted to the ethics committee for approval.
2. The researchers participating in this validation conscientiously followed the standard
operating procedures for clinical validation before, during and after the validation.
3. During the verification process, the researcher monitored the correctness and integrity
of the data in CRF.
4. According to the requirements of the case report form, researchers should faithfully,
carefully and carefully record all contents in CRF to ensure that the contents of the
case report form are true and reliable.
5. All observations and findings in clinical validation should be verified to ensure the
reliability of data, ensure that all conclusions in clinical validation are derived from
original data, and appropriate data management measures should be taken in clinical
validation and data processing.
3. Early Termination:
Define the principles and treatment for early termination of study, such as:
If serious adverse reactions occur in the trial, the clinical trial should be terminated in
time.
Serious deviations were found in the implementation of clinical trials and it was difficult
to evaluate the efficacy of surgical treatment.
The applicant requests termination or the administration requests termination of the
experiment.
