SensitivityNCT05185544
Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma
An observational study of Sensitivity, run by Shanghai Zhongshan Hospital.
Trial summary
Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sensitivity
- What is being tested?
- Neoadjuvant pemetrexed and cisplatin chemotherapy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
Who may be able to join
- 1. Aged between 18 and 75 years;
- 2. Lung adenocarcinoma;
- 3. The patient is able to receive neoadjuvant pemetrexed and cisplatin chemotherapy
- 4 .The patient is able to understand and comply with the study and has provided written informed consent.
Who cannot join
- 1. Patients with a history of lung surgery;
- 2. Postoperative pathology showed non-primary lung cancer;
- 3. Patients with a history of other tumors;
- 4. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
- 5. Unable to cooperate with the researchers because of dementia or cognitive decline
- 6. Other situations that are not in conformity with the standards and requirements of this trial.
About this study
Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
- Conditions
- Sensitivity
- Being tested
- Neoadjuvant pemetrexed and cisplatin chemotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant pemetrexed and cisplatin chemotherapyOther
neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma | neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma Receives: Other: Neoadjuvant pemetrexed and cisplatin chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Regression Grade
Measured: 1-2 Weeks after enrollment (after Surgery)
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 Jan 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SensitivityStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185544
- Sponsor's protocol ID
- B2021-Zhan
- Status last verified
- Dec 2021
- First submitted
- 18 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05185544
- Acronym / sponsor ID
- B2021-Zhan
- Conditions
- Sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (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.
Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma | – | Other: Neoadjuvant pemetrexed and cisplatin chemotherapyneoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma
Key inclusion criteria (4 listed)
- 1. Aged between 18 and 75 years;
- 2. Lung adenocarcinoma;
- 3. The patient is able to receive neoadjuvant pemetrexed and cisplatin chemotherapy
- 4 .The patient is able to understand and comply with the study and has provided written informed consent.
Key exclusion criteria (6 listed)
- 1. Patients with a history of lung surgery;
- 2. Postoperative pathology showed non-primary lung cancer;
- 3. Patients with a history of other tumors;
- 4. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
- 5. Unable to cooperate with the researchers because of dementia or cognitive decline
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 |
|---|---|---|
| Neoadjuvant pemetrexed and cisplatin chemotherapyneoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma | Other | neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma |
Primary outcome
Tumor Regression Grade
Time frame: 1-2 Weeks after enrollment (after Surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensitivity, run by Shanghai Zhongshan Hospital.
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 4 inclusion and 6 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Tumor Regression Grade (time frame: 1-2 Weeks after enrollment (after Surgery)). 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 11 Jan 2022.