Digestive System CancerNCT06054685
Association Between Body Composition and Digestive System Cancer Survival
An observational study of Digestive System Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Investigators intend to utilize clinical data from the Department of Oncology at Jiangsu Provincial People's Hospital to analyze changes in body composition in digestive system tumor patients before and after receiving anti-tumor drug treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Digestive System Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 30 Jan 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study includes digestive system tumor patients treated in the elderly comprehensive ward of Jiangsu Provincial People's Hospital from April 2023 to September 2024. Baseline surveys were conducted between April and May 2023 and between September and October 2024.
Who may be able to join
- Male or female patients aged between 18 and 85 years old.
- Patients with histologically confirmed digestive tract cancers, such as esophageal cancer, gastric cancer, small intestinal cancer, colorectal cancer, as well as pancreatic cancer, liver cancer, gallbladder cancer, etc.
- Patients admitted for anti-tumor-related drug treatment.
- Expected survival period of more than three months.
- ECOG PS score: < 4.
- No severe psychological disorders, physical disabilities, dementia, Alzheimer's disease, pulmonary tuberculosis, HIV/AIDS, or other infectious diseases.
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- Patients must have sufficient organ and bone marrow function, meeting the following criteria:
- Hematological criteria:
- Hemoglobin (Hb) ≥ 90 g/L (without blood transfusion in the past 28 days). Absolute neutrophil count (ANC) ≥ 1.5×109/L. Peripheral blood monocytes > 1500mm3. Platelet count (PLT) ≥ 100×109/L.
- Biochemical criteria:
- Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN). ALT and AST ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN. Creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate (CCr) ≥ 60 ml/min (Cockcroft-Gault formula).
- Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within seven days before enrollment and must voluntarily use appropriate contraception methods during the observation period and within six months after the last dose.
- Signed informed consent.
Who cannot join
- Female patients who are pregnant or breastfeeding.
- Patients with accompanying diseases, as judged by the investigator, pose a serious risk to patient safety or may affect the patient's ability to complete the study.
- Patients with poor compliance who refuse to undergo body composition measurements.
- Patients who experience a severe adverse event judged by the investigator as no longer suitable for continued participation in the study or those who become unexpectedly pregnant.
- Patients who are unwilling to continue in the clinical trial and insist on withdrawal.
- The investigator deems it necessary to terminate the study.
- Patients who were mistakenly included but did not meet the criteria.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A Study on the Association Between Body Composition and Survival in Digestive System Tumors and Immune Treatment Response
Investigators intend to utilize clinical data from the Department of Oncology at Jiangsu Provincial People's Hospital to analyze changes in body composition in digestive system tumor patients before and after receiving anti-tumor drug treatment. Investigators aim to uncover the association between baseline body composition and overall/progression-free survival in patients with digestive system tumors. Additionally, Investigators plan to investigate the relationship between changes in body composition during anti-tumor drug treatment (chemotherapy and immunotherapy) and the prognosis of tumor patients.
- Conditions
- Digestive System Cancer
- Medical subject headings
- Digestive System Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progress free survival
Measured: 2025-01-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start17 Apr 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054685
- Sponsor's protocol ID
- 2023-SR-339
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Association Between Body Composition and Survival in Digestive System Tumors and Immune Treatment Response
- ClinicalTrials.gov ID
- NCT06054685
- Acronym / sponsor ID
- 2023-SR-339
- Conditions
- Digestive System Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 26 Sep 2023 (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.
Investigators intend to utilize clinical data from the Department of Oncology at Jiangsu Provincial People's Hospital to analyze changes in body composition in digestive system tumor patients before and after receiving anti-tumor drug treatment. Investigators aim to uncover the association between baseline body composition and overall/progression-free survival in patients with digestive system tumors. Additionally, Investigators plan to investigate the relationship between changes in body composition during anti-tumor drug treatment (chemotherapy and immunotherapy) and the prognosis of tumor patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study includes digestive system tumor patients treated in the elderly comprehensive ward of Jiangsu Provincial People's Hospital from April 2023 to September 2024. Baseline surveys were conducted between April and May 2023 and between September and October 2024.
Key inclusion criteria (14 listed)
- Male or female patients aged between 18 and 85 years old.
- Patients with histologically confirmed digestive tract cancers, such as esophageal cancer, gastric cancer, small intestinal cancer, colorectal cancer, as well as pancreatic cancer, liver cancer, gallbladder cancer, etc.
- Patients admitted for anti-tumor-related drug treatment.
- Expected survival period of more than three months.
- ECOG PS score: < 4.
Key exclusion criteria (7 listed)
- Female patients who are pregnant or breastfeeding.
- Patients with accompanying diseases, as judged by the investigator, pose a serious risk to patient safety or may affect the patient's ability to complete the study.
- Patients with poor compliance who refuse to undergo body composition measurements.
- Patients who experience a severe adverse event judged by the investigator as no longer suitable for continued participation in the study or those who become unexpectedly pregnant.
- Patients who are unwilling to continue in the clinical trial and insist on withdrawal.
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
PFS
Time frame: 2025-01-30
Progress free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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.
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 Digestive System Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 14 inclusion and 7 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 10 Oct 2023. 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?
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?
PFS (time frame: 2025-01-30). 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 10 Oct 2023.