Pancreatic NeoplasmsNCT05187416
Correlation Between Elastic Modulus of Ultrasonic Shear Wave and Tumor Stromal Component in Pancreatic Cancer
An observational study of Pancreatic Neoplasms, run by Xijing Hospital at 1 site in China.
Trial summary
Pancreatic cancer is a gastrointestinal tumor with a high degree of malignancy. Currently, there are many first-line chemotherapy regimens in clinical practice, but the individual selection of chemotherapy regimens has not been unanimously recognized.This study is aimed at exploring the correlation between the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- two-dimensional shear wave elastography
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Oct 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cases of pancreatic cancer in Xijing Hospital
Who may be able to join
- Patients with resectable pancreatic cancer underwent ultrasound examination before surgery
- Conventional ultrasound can clearly show pancreatic space-occupying lesions and the elastic measurements show good images
- The patient agrees to receive ultrasound elasticity examination and signs informed consent
- All patients had no history of radiotherapy or chemotherapy before ultrasound examination
- All clinical case data and auxiliary examination data are complete and accessible.
Who cannot join
- Ultrasound evaluation was not performed before ultrasound-guided needle biopsy
- Conventional ultrasound could not clearly show pancreatic space-occupying lesions or poor elastic measurement images
- Patients who refuse to accept examination or give up treatment
- Patients receiving neoadjuvant chemotherapy or radiotherapy before ultrasound examination
- Incomplete clinical data and auxiliary examination data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Ming Yu, +8613991181250, yumingfmmu@126.com
About this study
Pancreatic cancer is a gastrointestinal tumor with a high degree of malignancy. Currently, there are many first-line chemotherapy regimens in clinical practice, but the individual selection of chemotherapy regimens has not been unanimously recognized.This study is aimed at exploring the correlation between the two-dimensional shear wave elastography (2D - SWE) parameters and pancreatic cancer stromal elements proportion through an ultrasound scan for resectable pancreatic cancer cases and postoperative pathological specimen analysis. Then determine if the pancreatic cancer two-dimensional shear wave elastography can guide clinicians selecting chemotherapy scheme by predicting tumor stromal elements .These results are expected to provide an effective non-invasive diagnostic basis for individualized treatment of pancreatic cancer.
- Conditions
- Pancreatic Neoplasms
- Being tested
- two-dimensional shear wave elastography
- Keywords
- 2D-SWE
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional shear wave elastographyDiagnostic test
Preoperative ultrasound elastography examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastic modulus measured by Ultrasonic shear wave and tumor stromal component assessed by pathological analysis in pancreatic cancer
Measured: Baseline (Preoperative ultrasound elastography examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187416
- Sponsor's protocol ID
- KY20212175-C-1
- Status last verified
- Oct 2021
- First submitted
- 20 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Elastic Modulus of Ultrasonic Shear Wave and Tumor Stromal Component in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05187416
- Acronym / sponsor ID
- KY20212175-C-1
- Conditions
- Pancreatic Neoplasms
- Keywords
- 2D-SWE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- 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.
Pancreatic cancer is a gastrointestinal tumor with a high degree of malignancy. Currently, there are many first-line chemotherapy regimens in clinical practice, but the individual selection of chemotherapy regimens has not been unanimously recognized.This study is aimed at exploring the correlation between the two-dimensional shear wave elastography (2D - SWE) parameters and pancreatic cancer stromal elements proportion through an ultrasound scan for resectable pancreatic cancer cases and postoperative pathological specimen analysis. Then determine if the pancreatic cancer two-dimensional shear wave elastography can guide clinicians selecting chemotherapy scheme by predicting tumor stromal elements .These results are expected to provide an effective non-invasive diagnostic basis for individualized treatment of pancreatic cancer.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cases of pancreatic cancer in Xijing Hospital
Key inclusion criteria (5 listed)
- Patients with resectable pancreatic cancer underwent ultrasound examination before surgery
- Conventional ultrasound can clearly show pancreatic space-occupying lesions and the elastic measurements show good images
- The patient agrees to receive ultrasound elasticity examination and signs informed consent
- All patients had no history of radiotherapy or chemotherapy before ultrasound examination
- All clinical case data and auxiliary examination data are complete and accessible.
Key exclusion criteria (5 listed)
- Ultrasound evaluation was not performed before ultrasound-guided needle biopsy
- Conventional ultrasound could not clearly show pancreatic space-occupying lesions or poor elastic measurement images
- Patients who refuse to accept examination or give up treatment
- Patients receiving neoadjuvant chemotherapy or radiotherapy before ultrasound examination
- Incomplete clinical data and auxiliary examination data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two-dimensional shear wave elastographyPreoperative ultrasound elastography examination | Diagnostic test | – |
Primary outcome
Elastic modulus measured by Ultrasonic shear wave and tumor stromal component assessed by pathological analysis in pancreatic cancer
Time frame: Baseline (Preoperative ultrasound elastography examination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No
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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.
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 Pancreatic Neoplasms, run by Xijing Hospital at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kunlong Duan (+8617795629885, 804868814@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elastic modulus measured by Ultrasonic shear wave and tumor stromal component assessed by pathological analysis in pancreatic cancer (time frame: Baseline (Preoperative ultrasound elastography examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.