Progression-Free SurvivalNCT06527001
Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer
An observational study of Progression-Free Survival and Overall Survival, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Ovarian cancer is one of the three major malignant tumors in gynecology, causing more than 200,000 deaths globally each year, with the highest mortality rate. However, due to its insidious onset and lack of specificity in clinical manifestations, nearly 70% of patients are in advanced stages upon diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progression-Free Survival, Overall Survival, Nutrition Aspect of Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a non-interventional retrospective study to collect clinical data from patients with advanced epithelial ovarian cancer who underwent bowel surgery in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of the University of Science and Technology of China from January 2017 to December 2023.All enrolled patients underwent cytoreductive surgery and completed follow-up registration according to NCCN guidelines.
Who may be able to join
- Patients with advanced epithelial ovarian cancer who underwent bowel surgery (PDS, IDS, and SCS);
- FIGO (2014) staging of stage III to IV;
- Diagnosis was made between January 2017 and December 2023; ④Complete relevant clinical data.
Who cannot join
- Combination of malignant tumors in other parts of the body not in remission or under treatment; ②Having an infectious disease in the infectious or active stage;
- Unknown status of visits to other hospitals and loss of visits; ④Not considered by the investigator to be suitable for enrollment or incomplete baseline information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer
Ovarian cancer is one of the three major malignant tumors in gynecology, causing more than 200,000 deaths globally each year, with the highest mortality rate. However, due to its insidious onset and lack of specificity in clinical manifestations, nearly 70% of patients are in advanced stages upon diagnosis. Ovarian cancer often spreads along the peritoneal surface of the abdominal and pelvic cavity and involves the intestines through direct extension or plasma membrane infiltration, resulting in impaired intestinal function and intestinal obstruction. Cytoreductive Surgery is a critical treatment for patients with ovarian cancer. Literature reports that about 60%-70% of patients with advanced ovarian cancer underwent bowel resection at the time of primary debulking surgery, with the main site of resection being the recto-sigmoid (48%-55%), followed by the rest of the colon (18%-20%) and the small bowel (6%-27%). Patients with bowel resection for ovarian cancer often have involvement of mesenteric lymph nodes (MLN), and the positive rate of MLN fluctuates from 37% - 79.4%, and the incidence of liver metastasis within 3 years in ovarian cancer patients with MLN involvement is 61.1%. However, ovarian cancer patients with bowel or liver involvement are susceptible to postoperative malnutrition due to their extensive surgery, as well as increased incidence of postoperative complications. Therefore, this study included patients who underwent bowel resection for ovarian cancer, and assessed the patients' MLN metastasis and nutritional status based on the relevant clinical indicators, in order to reduce the incidence of postoperative complications in patients with bowel resection, to improve the patients' prognosis, and to enhance the quality of life.
Read the detailed description
This is a non-interventional retrospective study to collect clinical data from patients with advanced epithelial ovarian cancer who underwent bowel surgery in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of the University of Science and Technology of China from January 2017 to December 2023. The information collected includes: age, preoperative body mass index (BMI), menopausal status, genetic test results, FIGO stage, type of bowel resection, duration of the operation, and depth of bowel infiltration, number of MLN resections, as well as nutritional status scores (NRS 2002 and PG-SGA), biochemical indices (serum albumin, prealbumin, total protein and so on), inflammatory indices (C-reactive protein, neutrophilic to lymphocyte ratio, platelet to lymphocyte ratio), and anthropometric parameters (body weight change, BMI). The aim of the clinical data analysis was to reduce the incidence of perioperative complications, improve the prognosis, and enhance the quality of life of patients with ovarian cancer after bowel surgery.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study and did not involve interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
Measured: 2 year
OS
OS was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.
Measured: 2 year
NRS 2002
Nutritional Risk Screening 2002 (NRS 20002) was primarily used to assess a patient's possible nutritional risk, and a score of ≥3 indicates that the patient is at risk of malnutrition or nutritional risk.
Measured: The scale was evaluated before surgery and at 4 months after surgery.
PG-SGA
Patient-Generated Subjective Global Assessment (PG-SGA) was primarily used to assess the nutritional status of tumor patients. Well nourished was 0-1 score, suspected or mild malnutrition was 2-3 score, moderate malnutrition was 4-8 score, severe malnutrition ≥9 score.
Measured: The scale was evaluated before surgery and at 4 months after surgery.
BMI
Body mass index (BMI) was obtained by dividing weight in kilograms by height in meters squared. Normal was 18.5-24 score, overweight was 24-28 score, and obesity ≥28 score.
Measured: The index was evaluated before surgery and at 4 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start16 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progression-Free SurvivalStudies of the same condition, open and under way.
- 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
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ying Zhou, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527001
- Sponsor's protocol ID
- Ying Zhou-1
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Mesenteric Lymph Node Metastasis and Nutritional Status After Bowel Resection for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06527001
- Acronym / sponsor ID
- Ying Zhou-1
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 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.
Ovarian cancer is one of the three major malignant tumors in gynecology, causing more than 200,000 deaths globally each year, with the highest mortality rate. However, due to its insidious onset and lack of specificity in clinical manifestations, nearly 70% of patients are in advanced stages upon diagnosis. Ovarian cancer often spreads along the peritoneal surface of the abdominal and pelvic cavity and involves the intestines through direct extension or plasma membrane infiltration, resulting in impaired intestinal function and intestinal obstruction. Cytoreductive Surgery is a critical treatment for patients with ovarian cancer. Literature reports that about 60%-70% of patients with advanced ovarian cancer underwent bowel resection at the time of primary debulking surgery, with the main site of resection being the recto-sigmoid (48%-55%), followed by the rest of the colon (18%-20%) and the small bowel (6%-27%). Patients with bowel resection for ovarian cancer often have involvement of mesenteric lymph nodes (MLN), and the positive rate of MLN fluctuates from 37% - 79.4%, and the incidence of liver metastasis within 3 years in ovarian cancer patients with MLN involvement is 61.1%. However, ovarian cancer patients with bowel or liver involvement are susceptible to postoperative malnutrition due to their extensive surgery, as well as increased incidence of postoperative complications. Therefore, this study included patients who underwent bowel resection for ovarian cancer, and assessed the patients' MLN metastasis and nutritional status based on the relevant clinical indicators, in order to reduce the incidence of postoperative complications in patients with bowel resection, to improve the patients' prognosis, and to enhance the quality of life.
Detailed description
This is a non-interventional retrospective study to collect clinical data from patients with advanced epithelial ovarian cancer who underwent bowel surgery in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of the University of Science and Technology of China from January 2017 to December 2023. The information collected includes: age, preoperative body mass index (BMI), menopausal status, genetic test results, FIGO stage, type of bowel resection, duration of the operation, and depth of bowel infiltration, number of MLN resections, as well as nutritional status scores (NRS 2002 and PG-SGA), biochemical indices (serum albumin, prealbumin, total protein and so on), inflammatory indices (C-reactive protein, neutrophilic to lymphocyte ratio, platelet to lymphocyte ratio), and anthropometric parameters (body weight change, BMI). The aim of the clinical data analysis was to reduce the incidence of perioperative complications, improve the prognosis, and enhance the quality of life of patients with ovarian cancer after bowel surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a non-interventional retrospective study to collect clinical data from patients with advanced epithelial ovarian cancer who underwent bowel surgery in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of the University of Science and Technology of China from January 2017 to December 2023.All enrolled patients underwent cytoreductive surgery and completed follow-up registration according to NCCN guidelines.
Key inclusion criteria (3 listed)
- Patients with advanced epithelial ovarian cancer who underwent bowel surgery (PDS, IDS, and SCS);
Key exclusion criteria (2 listed)
- Combination of malignant tumors in other parts of the body not in remission or under treatment; ②Having an infectious disease in the infectious or active stage;
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 |
|---|---|---|
| No interventionThis is an observational study and did not involve interventions. | Other | – |
Primary outcome
PFS
Time frame: 2 year
PFS is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
OS
Time frame: 2 year
OS was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.
NRS 2002
Time frame: The scale was evaluated before surgery and at 4 months after surgery.
Nutritional Risk Screening 2002 (NRS 20002) was primarily used to assess a patient's possible nutritional risk, and a score of ≥3 indicates that the patient is at risk of malnutrition or nutritional risk.
PG-SGA
Time frame: The scale was evaluated before surgery and at 4 months after surgery.
Patient-Generated Subjective Global Assessment (PG-SGA) was primarily used to assess the nutritional status of tumor patients. Well nourished was 0-1 score, suspected or mild malnutrition was 2-3 score, moderate malnutrition was 4-8 score, severe malnutrition ≥9 score.
BMI
Time frame: The index was evaluated before surgery and at 4 months after surgery.
Body mass index (BMI) was obtained by dividing weight in kilograms by height in meters squared. Normal was 18.5-24 score, overweight was 24-28 score, and obesity ≥28 score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Progression-Free Survival
Not yet recruitingObservational study
Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast
Malignant Phyllodes Tumor of the Breast
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingObservational study
Toxicity of Intensive First-Line Treatment for Adult Burkitt Lymphoma: A Retrospective Observational Study
Adult Burkitt Lymphoma, Chemotherapy-Related Toxicity
RecruitingPhase 3
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments
Unresectable Gastrointestinal Stromal Tumor (GIST), Locally Advanced Gastrointestinal Stromal Tumor (GIST)
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.
Ying Zhou, MD study chair
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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 Progression-Free Survival and Overall Survival, run by Anhui Provincial 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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
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: 2 year). The study lists 5 primary outcomes in all. 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 Jul 2024.