Breast CancerNCT07319767
Comparing the TDTP-RECIST With RECIST 1.1 and Other Volumetric Evaluation Methods for Assessing the Therapeutic Efficacy of Irregular Malignant Tumors
An observational study of Breast Cancer and Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study looks at better ways to measure how tumors respond to treatment before surgery. Today, doctors often use RECIST 1.1 (Response Evaluation Criteria in Solid Tumors), which measures the longest diameter across a tumor on an axial scan. This can be unreliable for tumors with irregular shapes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2024to 15 Oct 2025
- 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 80 years
- All sexes
- Adult, Older adult
Study population: This study includes adults who were treated and had surgery at Zhongshan Hospital, Fudan University (Shanghai, China) Shenzhen University General Hospital (Shenzhen, China), Tianjin Cancer Hospital Airport Hospital (Tianjin, China), between May 2019 to Dec. 2024. All participants had one of the following cancers: biliary tract cancer (intrahepatic or hilar cholangiocarcinoma, or gallbladder cancer), breast cancer (invasive ductal carcinoma), or pancreatic ductal adenocarcinoma. They received treatment given before surgery to shrink the tumor (neoadjuvant or "conversion" therapy) and then underwent surgical removal of the tumor.
Who may be able to join
- Pathologically confirmed malignancy of one of the following types: biliary tract cancer (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, or gallbladder cancer), breast cancer, or pancreatic ductal adenocarcinoma
- Age 18 to 80 years (inclusive), any sex
- Received neoadjuvant or conversion therapy before surgery; no prior anti-cancer therapy before that course
- Underwent tumor surgical resection or biopsy after completion of neoadjuvant/conversion therapy
- Available baseline and preoperative imaging with the same modality (contrast-enhanced CT or MRI) at both time points for response evaluation
- Complete postoperative pathology report and follow-up data available
Who cannot join
- History of another malignancy or concurrent multiple primary cancers
- Missing imaging or inconsistent imaging evaluation across time points (e.g., absent scans or differing modalities that preclude paired assessment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Comparing the TDTP-RECIST With RECIST 1.1 and Other Volumetric Evaluation Methods for Assessing the Therapeutic Efficacy of Irregular Malignant Tumors
This study looks at better ways to measure how tumors respond to treatment before surgery. Today, doctors often use RECIST 1.1 (Response Evaluation Criteria in Solid Tumors), which measures the longest diameter across a tumor on an axial scan. This can be unreliable for tumors with irregular shapes. The investigator will compare a new, simple 3-dimensional method called TDTP-RECIST (Three-Dimensional Twelve-Point RECIST) with RECIST 1.1 and other volume-based methods to see which one matches best with what is found in the tumor after it is removed.
This is a retrospective study at Zhongshan Hospital, Fudan University (Shanghai, China), Shenzhen University General Hospital (Shenzhen, China), and Tianjin Cancer Hospital Airport Hospital (Tianjin, China). The investigator will review past medical records and CT or MRI scans from adults (18-80 years) who had biliary tract cancer, breast ductal carcinoma, or pancreatic ductal adenocarcinoma. All included patients received neoadjuvant or "conversion" therapy (treatment given before surgery to shrink the tumor) and then had surgery between 2019 and 2024. The investigator will not contact participants or change their care.
Read more
On the scans done before treatment and before surgery, the investigator will calculate tumor response using several methods (RECIST 1.1 and volume-based methods, including TDTP-RECIST). The investigator will compare these imaging results with the "pathology response" seen in the removed tumor tissue (how much living cancer is left). The investigator will also see how well the imaging methods relate to clear surgical margins (R0 resection, meaning no cancer at the cut edge), time without cancer coming back (recurrence-free survival), and overall survival.
About 120 participants are expected. The analysis is planned from August to December 2025. There are no study visits, procedures, or treatments for participants, so risks are minimal. There is no direct benefit to participants. Findings may help doctors choose better tools to judge treatment response for irregular tumors in the future. All data will be de-identified. The hospital's ethics committee has approved this retrospective review and waived individual consent. Sponsor: Zhongshan Hospital, Fudan University. Location: Shanghai, China.
- Conditions
- Breast Cancer, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)
- Medical subject headings
- Breast Neoplasms, Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic ductal adenoma cohort | Not described | |
| Biliary tract cancer cohort | Not described | |
| Breast cancer cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRR
Pathology response rate
Measured: 2019-2024
Secondary outcomes (3)
R0 resection rate
margin-negative resection rate
Measured: 2019-2024
RFS
Recurrent free survival
Measured: 2019-2025
OS
Overall survival
Measured: 2019-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start14 May 2024
- Primary completion5 Jul 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen University General Hospital, Tianjin Cancer Hospital Airport Hospital
- Responsible party
- Principal investigator, Jia Fan, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319767
- Sponsor's protocol ID
- ZS-TDTP-RECIST
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the TDTP-RECIST With RECIST 1.1 and Other Volumetric Evaluation Methods for Assessing the Therapeutic Efficacy of Irregular Malignant Tumors
- ClinicalTrials.gov ID
- NCT07319767
- Acronym / sponsor ID
- ZS-TDTP-RECIST
- Conditions
- Breast Cancer, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shenzhen University General Hospital, Tianjin Cancer Hospital Airport Hospital
- Study start
- 14 May 2024 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 6 Jan 2026 (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.
This study looks at better ways to measure how tumors respond to treatment before surgery. Today, doctors often use RECIST 1.1 (Response Evaluation Criteria in Solid Tumors), which measures the longest diameter across a tumor on an axial scan. This can be unreliable for tumors with irregular shapes. The investigator will compare a new, simple 3-dimensional method called TDTP-RECIST (Three-Dimensional Twelve-Point RECIST) with RECIST 1.1 and other volume-based methods to see which one matches best with what is found in the tumor after it is removed.
This is a retrospective study at Zhongshan Hospital, Fudan University (Shanghai, China), Shenzhen University General Hospital (Shenzhen, China), and Tianjin Cancer Hospital Airport Hospital (Tianjin, China). The investigator will review past medical records and CT or MRI scans from adults (18-80 years) who had biliary tract cancer, breast ductal carcinoma, or pancreatic ductal adenocarcinoma. All included patients received neoadjuvant or "conversion" therapy (treatment given before surgery to shrink the tumor) and then had surgery between 2019 and 2024. The investigator will not contact participants or change their care.
On the scans done before treatment and before surgery, the investigator will calculate tumor response using several methods (RECIST 1.1 and volume-based methods, including TDTP-RECIST). The investigator will compare these imaging results with the "pathology response" seen in the removed tumor tissue (how much living cancer is left). The investigator will also see how well the imaging methods relate to clear surgical margins (R0 resection, meaning no cancer at the cut edge), time without cancer coming back (recurrence-free survival), and overall survival.
About 120 participants are expected. The analysis is planned from August to December 2025. There are no study visits, procedures, or treatments for participants, so risks are minimal. There is no direct benefit to participants. Findings may help doctors choose better tools to judge treatment response for irregular tumors in the future. All data will be de-identified. The hospital's ethics committee has approved this retrospective review and waived individual consent. Sponsor: Zhongshan Hospital, Fudan University. Location: Shanghai, China.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pancreatic ductal adenoma cohort | – | – |
| Biliary tract cancer cohort | – | – |
| Breast cancer cohort | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study includes adults who were treated and had surgery at Zhongshan Hospital, Fudan University (Shanghai, China) Shenzhen University General Hospital (Shenzhen, China), Tianjin Cancer Hospital Airport Hospital (Tianjin, China), between May 2019 to Dec. 2024. All participants had one of the following cancers: biliary tract cancer (intrahepatic or hilar cholangiocarcinoma, or gallbladder cancer), breast cancer (invasive ductal carcinoma), or pancreatic ductal adenocarcinoma. They received treatment given before surgery to shrink the tumor (neoadjuvant or "conversion" therapy) and then underwent surgical removal of the tumor.
Key inclusion criteria (6 listed)
- Pathologically confirmed malignancy of one of the following types: biliary tract cancer (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, or gallbladder cancer), breast cancer, or pancreatic ductal adenocarcinoma
- Age 18 to 80 years (inclusive), any sex
- Received neoadjuvant or conversion therapy before surgery; no prior anti-cancer therapy before that course
- Underwent tumor surgical resection or biopsy after completion of neoadjuvant/conversion therapy
- Available baseline and preoperative imaging with the same modality (contrast-enhanced CT or MRI) at both time points for response evaluation
Key exclusion criteria (2 listed)
- History of another malignancy or concurrent multiple primary cancers
- Missing imaging or inconsistent imaging evaluation across time points (e.g., absent scans or differing modalities that preclude paired assessment)
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
PRR
Time frame: 2019-2024
Pathology response rate
3 secondary outcomes
R0 resection rate
Time frame: 2019-2024
RFS
Time frame: 2019-2025
OS
Time frame: 2019-2025
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 6 Apr 2026.
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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.
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 Breast Cancer and Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), run by Shanghai Zhongshan 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 6 inclusion and 2 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 6 Apr 2026. 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?
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?
PRR (time frame: 2019-2024). 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 6 Apr 2026.