Xiaoqin Luo, Ph.D

Hexiang Yang, Ph.D

The study investigates the impact of nutritional status on the clinical outcomes of cancer patients in Shaanxi Province undergoing chemoradiotherapy. It focuses on understanding how diet and nutrition affect the effectiveness and side effects of cancer treatments.

Study Purpose and Content: The research aims to investigate the nutritional status and trends in cancer patients at different stages of chemoradiotherapy in Shaanxi Province.

Registry Procedures: The study will recruit patients from 20 hospitals across the province, tracking their nutritional status, disease condition, and quality of life through various stages of treatment.

Quality Control: Nutritional assessments are to be conducted at specific intervals, and all research staff are required to undergo training for consistency in data collection and patient evaluation.

Ethical Considerations: The study ensures informed consent from participants and confidentiality of personal information, with approval from the ethics committee of Xi'an Jiaotong University Medical College.

Data Collection and Analysis: Data will be gathered through detailed patient surveys, laboratory tests, and physical measurements, with subsequent analysis to establish a predictive model for cancer patient survival based on nutritional indicators.

Tumor tissue, paracancerous tissue, Serum, Fecal samples

Nutrition and Cancer Outcomes in Shaanxi Chemoradiotherapy

Impact of Nutritional Status on Clinical Outcomes in Cancer Patients Receiving Chemoradiotherapy in Shaanxi Province

The study intends to share IPD with other researchers for advancing scientific understanding and improving patient care. The shared data will include anonymized participant information, such as demographic details, clinical outcomes, and treatment responses. The data will be stripped of any identifiers to ensure participant confidentiality.

The accuracy of the height was 0.5cm, and this value should be noted if there was ascites, systemic edema, and huge tumors.

Weight accuracy to 0.2kg,and this value should be noted if there was ascites, systemic edema, and huge tumors.

the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0)

Xiaoqin Luo

Professor

Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Postoperative Complications

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection

Control patients will not be received any intervention

Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection

vitamin D

control

Zahra Vahdat Shariatpanahi, MD, PhD

Vitamin D supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.

A randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000 IU). Patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.

Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery

Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection

Complications in operating room, recovery room, ICU and neurosurgery ward

Mortality during hospitalization or 1 month after surgery

Shahid Beheshti University

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Tissue Adhesions

Cysts

Ovarian Cysts

Myoma

Cicatrix

Fibrosis

Pathological Conditions, Anatomical

Oculocerebral Syndrome With Hypopigmentation

Hyaluronic Acid

Adjuvants, Immunologic

Immunologic Factors

Viscosupplements

Protective Agents

Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery

Saline

Cross-linked Hyaluronan Hydrogel

Zhenyu Zhang, MD, PhD

The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery

Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial

The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.

modified American Fertility Society (mAFS) score of ovaries/tubes

The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.

modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)

Adhesion extent (throughout abdominopelvic cavity)

Adhesion severity (throughout abdominopelvic cavity)

Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.

BioRegen Biomedical (CHangzhou) Co., Ltd

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

TSENG CHIA-CHENG

The investigators conduct this prospective study and wish to elucidate the association of serial change of body composition, serum adipo-myokines and adverse effect of chemotherapy and lung cancer prognosis

Recently, the skeletal muscle was viewed as having biochemical function in additional to traditional biomechanical function. What's more important is that muscles could synthesize and release adipo-myokines during contraction. The adipo-myokines can affect muscle regeneration, muscle atrophy, muscle mass, autophagy, fatty acid oxidation and mitochondrial biosynthesis.Studies have also found that exercise can promote the function of macrophages and regulate both pro-inflammatory and anti-inflammatory phenotypes, helping the body to establish a stable immune balance.

Since body composition can illustrate malnutrition status and cancer cachexia present, and body composition can be affected by serum adipo-myokines level. Therefore, the investigators conduct this study and wish to see the association of serial body composition and serum adipo-myokines changes with lung cancer clinical outcomes and adverse effect of any anti-cancer regimen.

Adipo-myokines concentrations will be checked using residual plasma specimens on the date of before therapy, 4 weeks after therapy and 12 weeks after therapy

The Alterations of Metabolic Adipo-myokines and Body Composition in End Stage Lung Cancer

The Clinical Significance of Metabolic Adipo-myokines and Alterations of Body Composition in Patients With End Stage Lung Cancer

assessing the change of white blood cell count among week 0, week 4 and week 12

assessing the change of percentage of body fat among week 0, week 4 and week 12

assessing the change of total body water percentage among week 0, week 4 and week 12

assessing the change of soft lean mass percentage among week 0, week 4 and week 12

assessing the change of plasma CEA concentration among week 0, week 4 and week 12

assessing the change of plasma albumin concentration among week 0, week 4 and week 12

assessing the change of plasma myostatin concentration among week 0, week 4 and week 12

assessing the change of plasma FSTL-1 concentration among week 0, week 4 and week 12

assessing the change of plasma IL-6 concentration among week 0, week 4 and week 12

assessing the change of plasma irisin concentration among week 0, week 4 and week 12

assessing the change of plasma adiponectin concentration among week 0, week 4 and week 12

assessing the change of plasma MCP-1 concentration among week 0, week 4 and week 12

assessing the change of plasma aquaporin concentration among week 0, week 4 and week 12

Chang Gung Memorial Hospital

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Patients in Gradual Goal-dose EN group will receive increased calories gradually by enteral nutrition and will reach the 80% of target energy by enteral nutrition at day 8.

Patients in immediate Goal-dose EN group will reach the 100% of target energy by enteral nutrition at day 3 after abdominal surgery.

Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both of the two group will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first.

Enteral nutrition

Xinying Wang, MD

Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Patients after abdominal surgery will receive enteral nutrition for 2 days, if she/he can tolerate 30% of goal-dose EN, then she/he will be randomized to Gradual or immediate Goal-dose EN group at day 3. Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first. The primary and secondary outcomes will be collected.

Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients

Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients: A Clinical Randomized Controlled Trial

Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

The total energy patients received during the intervention.

Diarrhea, vomiting, abdominal distention or cramping and abdominal pain.

Albumin, pre-albumin, transferrin and retinol conjugated protein

All deaths reported in all enrolled patients.

Peking Union Medical College Hospital

Chinese PLA General Hospital

First Affiliated Hospital, Sun Yat-Sen University

Xijing Hospital

West China Hospital

Xinqiao Hospital of Chongqing

Second Affiliated Hospital, School of Medicine, Zhejiang University

Changhai Hospital

Shanghai 10th People's Hospital

The Second Affiliated Hospital of Harbin Medical University

The Affiliated Hospital of Qingdao University

First Affiliated Hospital of Kunming Medical University

Jinling Hospital, China

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Women with one or more pregnancies any time after breast cancer diagnosis

Women with no subsequent pregnancies after breast cancer diagnosis

Clinical outcomes

The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer

The incidence of pregnancy following breast cancer diagnosis will be computed as the ratio between the number of breast cancer survivors in the pregnant cohort and the total number of eligible patients included in the study.

To evaluate the prognostic impact of pregnancy following breast cancer diagnosis in BRCA mutated survivors, two survival endpoints will be compared between patients with and without a pregnancy following breast cancer diagnosis: disease-free survival and overall survival. Disease-free survival event is defined by the occurrence of one of the following invasive events: local recurrence, distant metastases, contralateral or ipsilateral breast tumor, second primary malignancy, or death from any cause. Overall survival event is defined as death from any cause.

Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors

Jules Bordet Institute

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Intraductal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

The EUS follow-up will be conducted at baseline and every 12 months thereafter. For patients with new WF or HRS in the evaluation, the follow-up physician and the patient can jointly decide whether to perform EUS evaluation in the 6 or 3 month intensive follow-up.

Endoscopic ultrasound

Xi Wu, M.D.

Shengyu Zhang, M.D.

Yiran Su, MD candidate

Study objective: To establish a long-term follow-up cohort of patients with IPMN, study the follow-up, clinical outcomes and prognostic factors of patients with IPMN, and provide a basis for clinical decisions and guidelines.

Study design: This is a real world, multicenter, prospective, observational cohort study

Baseline assessment will be conducted on IPMN patients who meet the inclusion conditions and are included in the study with informed consent, including: ① demographic characteristics (such as age, gender, etc.); ② Clinical features (such as symptoms, complications, past history, family history, living/eating habits); ③ Characteristics of laboratory indicators (such as pancreatic function, liver enzyme, bile duct enzyme, CA199, CEA in blood; CA199, CEA in cystic fluid, etc.); ④ Imaging features \* (such as multiple or single lesions, diameter of cyst, whether there are mural nodules, diameter of main pancreatic duct, etc.); ⑤ Endoscopic ultrasound (EUS) features \* (such as: cyst location, echo, maximum diameter, whether the cyst wall is thickened, wall nodules, the connection between the cyst and the main pancreatic duct, laser confocal endoscopy features, etc.); ⑥ Pathological information (cytology of cystic fluid; cytological smear of cystic lesion puncture, histopathology); ⑥ Molecular characteristics of cyst fluid (such as proteomics/mass spectrometry, new biomarkers, next generation sequencing (NGS), flora characteristics, etc.); ⑦ Treatment information (such as current medication, whether to have received endoscopic treatment, etc.).

The follow-up contents include: outpatient follow-up (symptoms, laboratory indicators; keeping peripheral blood samples) every six months;, imaging follow-up (including enhanced pancreatic MR and EUS imaging; the first pancreatic MRI follow-up was conducted 6 months after enrollment to determine the stability of the lesions) at baseline and every 12 months thereafter.

During the follow-up, if the patient died of various causes, the follow-up will be terminated; If enhanced nuclear magnetic resonance imaging or EUS imaging of the pancreas indicates worrisome features (WFs) or high-risk features (High risk stigmata, HRS), EUS-FNA ± nCLE should be performed (when performing EUS, perform contrast-enhanced ultrasonography on cystic lesions with mural nodules, and collect cystic fluid when puncturing some cystic lesions with sufficient volume).

If the cytological/histological pathological results of FNA indicate cancer or high grade dysplasia (HGD), or/and cystic fluid cytological results are positive, surgical treatment is recommended; If the FNA and cyst fluid cytology results are negative, the patients with WF will be followed up 6 months later, while the HRS patients will be followed up 3 months later (whether to accept EUS examination is decided jointly by the follow-up physician and the patient). It is suggested to review EUS-FNA ± nCLE according to the imaging results. If the patient was advised to receive surgical treatment due to IPMN, the follow-up was terminated.

Baseline sample includes 20ml blood sample, 1 oral flora swab and 1 stool sample.

Follow-up samples include 10mL blood sample and remaining samples of pancreatic puncture tissue and/or cyst fluid during EUS

A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm

Patient died or was recommended for surgical treatment.

High-risk stigmata refers to obstructive jaundice, enhancing mural nodules or an associated solid component, and those with an MPD ≥10 mm. Worrisome features refer to acute pancreatitis, cyst size ≥30 mm, thickened/enhancing cyst wall, MPD measuring 5-9.9 mm, nonenhancing mural nodules, and abrupt change in MPD caliber with distal atrophy of the pancreatic gland.

Beijing Hospital

Tongji Hospital

The First Affiliated Hospital of Xiamen University

associate professor

Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery.

Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery.

Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 or at day 8 after abdominal surgery.

Parenteral Nutrition

Patients will be randomized to early PN group or late PN group at day 3 after abdominal surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Patients after abdominal surgery will attempt enteral nutrition support for 2 days, if she/he can not tolerate 30% of target energy, then she/he will be randomized to early PN group or late PN group at day 3. Patients in early PN group will receive supplemental parenteral nutrition at day 3 while patients in late PN group will not receive supplemental parenteral nutrition until day 8 after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.

Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients

Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial

Invasion of the host organism by microorganisms that can cause pathological conditions or diseases

The length of patients stay in hospital after operation

Diarrhea, vomiting, abdominal distention or cramping and abdominal pain

The total energy patients received during the intervention

Professor, Chief of Clinical Nutrition Service

The eligible patient population of this study will comprise of advanced 2nd line NSCLC patients who are screened for two randomised clinical trials (RCTs) sponsored by AstraZeneca (AZ): SELECT-1 and SELECT-2 trials, but who do not meet eligibility criteria for those trials

Non interventional prospective data collection

Data Collection

Gabriella Mariani, MD

The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

The LUMINIST study will enrol patients who are ineligible for the SELECT-1 (NCT01933932) or SELECT-2 (NCT01750281)RCTs. Within this NIS patients will be followed longitudinally for treatment information and outcomes. The final dataset will enable linkage at the individual patient level of the clinical information datasets collected within LUMINIST to the exploratory biomarker data generated from samples collected as part of SELECT-1 screening. This will enable the examination of various molecular markers in patients with v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type and some KRAS mutation positive (KRAS+) patients. The LUMINIST study aims to enable the investigation of various molecular segments in NSCLC, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. The availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. The determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.

All samples used in the study are collected under the auspices of the SELECT 1 study screening. Luminist provides the clinical data to correlate the with sample results.

LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

The main outcomes will be stratified on biomarkers if interest and line of therapy

Prevalence of each biomarker will be calculated as the percentage of patients presenting a mutation/alteration/amplification

Treatments will be described by biomarkers to identify any emerging pattern.

Regression model will be used to estimate risk factors for non-response or resistance to standards of care, notably known and emerging biomarkers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutrition and Cancer Outcomes in Shaanxi Chemoradiotherapy	NCT06219083	Cancer Chemoradiothera... Nutrition, Heal... Oncology Clinical Outcom...		18 Years -	Health Science Center of Xi'an Jiaotong University
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery	NCT03248544	Brain Neoplasms	vitamin D control	18 Years -	Shahid Beheshti University
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions	NCT02166554	Myomas Ovary Cysts Endometriotic C... Adhesions	Saline Cross-linked Hy...	18 Years - 45 Years	BioRegen Biomedical (CHangzhou) Co., Ltd
The Alterations of Metabolic Adipo-myokines and Body Composition in End Stage Lung Cancer	NCT06060262	Lung Cancer Met...		20 Years - 100 Years	Chang Gung Memorial Hospital
Gradual Versus Immediate Goal-dose Enteral Nutrition in Abdominal Surgery Patients	NCT03117348	Enteral Nutriti... Postoperative P... Digestive Syste...	Enteral nutriti...	18 Years - 80 Years	Jinling Hospital, China
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients	NCT03673306	Breast Cancer	Clinical outcom...	18 Years - 40 Years	Jules Bordet Institute
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery	NCT03248544	Brain Neoplasms	vitamin D control	18 Years -	Shahid Beheshti University
A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm	NCT05593393	IPMN, Pancreati...	Endoscopic ultr...	18 Years -	Peking Union Medical College Hospital
Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients	NCT03115957	Digestive Syste...	Parenteral Nutr...	18 Years - 80 Years	Jinling Hospital, China
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study	NCT02300831	NSCLC	Data Collection	-	AstraZeneca
Nutrition and Cancer Outcomes in Shaanxi Chemoradiotherapy	NCT06219083	Cancer Chemoradiothera... Nutrition, Heal... Oncology Clinical Outcom...		18 Years -	Health Science Center of Xi'an Jiaotong University

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