Ampullary AdenomaNCT06435767
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy
An observational study of Ampullary Adenoma and Chemotherapy Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ampullary Adenoma, Chemotherapy Effect
- What is being tested?
- Adjuvant chemotherapy
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 85 years
- All sexes
- Adult, Older adult
Study population: In this international, retrospective cohort study, the cohort of Chinese enrolled patients who underwent curative surgery for AA at the National Cancer Center of China, Chinese Academy of Medical Sciences, Cancer Hospital, from January 1, 1998, to December 31, 2020 (NCC cohort). The Ethics Committee of the National Cancer Center of China approved the study. Informed consent was secured from participants, authorizing the utilization for potential research. Additionally, patients with AA between January 1, 2004, and December 31, 2017, in the surveillance, epidemiology and end results program were collected as the Western cohort. In which, 12 registries were enrolled including Alaska Natives, California, Connecticut, Georgia, Hawaii, Iowa, Kentucky, Louisiana, New Jersey, New Mexico, Seattle (Puget Sound), and Utah.
Who may be able to join
- Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection
Who cannot join
- patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Zheng Li, M.D., 18745750740, drlizheng1008@126.com
About this study
Official title: Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study
Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.
log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.
In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.
- Conditions
- Ampullary Adenoma, Chemotherapy Effect
- Being tested
- Adjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapyDrug
In the Cancer Hospital, postoperative chemotherapy regimens and doses were planned by oncologists, with adjustments made based on drug toxicities or tumor responses.
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of adjuvant chemotherapy(ACT)
The association between ACT and Overall Survival (OS) of patients
Measured: 1 year
Secondary outcomes (2)
The role of adjuvant chemotherapy(ACT)
The association between ACT and Cancer-specific Survival (CSS) of patients
Measured: 1 year
The role of adjuvant chemotherapy(ACT)
The association between ACT and Recurrence-free Survival (RFS) of patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ampullary AdenomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Bing Zhao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435767
- Sponsor's protocol ID
- CICAMS
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06435767
- Acronym / sponsor ID
- CICAMS
- Conditions
- Ampullary Adenoma, Chemotherapy Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 30 May 2024 (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.
Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.
log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.
In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In this international, retrospective cohort study, the cohort of Chinese enrolled patients who underwent curative surgery for AA at the National Cancer Center of China, Chinese Academy of Medical Sciences, Cancer Hospital, from January 1, 1998, to December 31, 2020 (NCC cohort). The Ethics Committee of the National Cancer Center of China approved the study. Informed consent was secured from participants, authorizing the utilization for potential research. Additionally, patients with AA between January 1, 2004, and December 31, 2017, in the surveillance, epidemiology and end results program were collected as the Western cohort. In which, 12 registries were enrolled including Alaska Natives, California, Connecticut, Georgia, Hawaii, Iowa, Kentucky, Louisiana, New Jersey, New Mexico, Seattle (Puget Sound), and Utah.
Key inclusion criteria (1 listed)
- Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection
Key exclusion criteria (1 listed)
- patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information
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 |
|---|---|---|
| Adjuvant chemotherapyIn the Cancer Hospital, postoperative chemotherapy regimens and doses were planned by oncologists, with adjustments made based on drug toxicities or tumor responses. | Drug | – |
Primary outcome
The role of adjuvant chemotherapy(ACT)
Time frame: 1 year
The association between ACT and Overall Survival (OS) of patients
2 secondary outcomes
The role of adjuvant chemotherapy(ACT)
Time frame: 1 year
The role of adjuvant chemotherapy(ACT)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
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 Ampullary Adenoma and Chemotherapy Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 1 inclusion and 1 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 30 May 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of adjuvant chemotherapy(ACT) (time frame: 1 year). 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 30 May 2024.