Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Fibrocystic Breast Disease

Skin Diseases

300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival.

100 Benign disease volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

100 Healthy volunteers whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

Zefei Jiang, Doctor

Zhimin Shao, Doctor

Tao Ouyang, Doctor

Erwei Song, Doctor

Ning Liao, Doctor

Xiaojia Wang, Doctor

Zhongsheng Tong, Doctor

The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China.

The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.

The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

A longitudinal, multi-center, prospective study will be conducted in MBC patients to evaluate the ability of CTC to predict the patients' prognosis. A separate population of healthy and benign disease subjects will serve as controls to compare the CTC incidence in this control group versus the MBC group at baseline. Correlation between CTC and radiographic response to the systemic therapies in the MBC study group will also be assessed.

300 MBC patients, each of whom will provide a series of at least 3 blood draws (baseline, 3-4 weeks and 6-8 weeks after the initiation of the systemic therapy) for CTC analysis, will be enrolled. All MBC patients will be followed for a maximum of 36 months for disease progression and survival.

200 healthy and benign disease volunteers, each of whom will donate blood 1 time for CTC analysis, will be enrolled as controls.

China CellSearch Study

A Multi-Center, Prospective Study to Evaluate the Ability of CTC Enumeration Using the CellSearch® Circulating Tumor Cell Kit to Predict Prognosis and to Assess the Agreement Between CTC and Imaging Determined Response in MBC Patients 一项评价CellSearch® 循环肿瘤细胞检测试剂盒对复发转移性乳腺癌患者进行循环肿瘤细胞检测 以预测病人预后的能力及循环肿瘤细胞检测和影像学疗效判断之间一致性的多中心、前瞻性的研究

Johnson & Johnson Medical, China

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

laparoscopic left colonic resection

open left colonic resection

Marco Braga, MD

The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.

268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.

Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

Laparoscopic Versus Open Left Colonic Resection

Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial

Università Vita-Salute San Raffaele

Marco Braga MD

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Wounds and Injuries

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Rupture

Lacerations

Ovarian Cancer

Ovarian Epithelial Cancer

A tear sample (\~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an "eye wash" method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed.

Tear collection

V. Suzanne Klimberg, MD

This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.

Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.

Analyzing the Composition of Tears to Identify Cancer

ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)

Tenenbaum Family Foundation

University of Arkansas

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
China CellSearch Study	NCT01116869	Metastatic Brea... Benign Breast D...		18 Years - 70 Years	Johnson & Johnson Medical, China
Laparoscopic Versus Open Left Colonic Resection	NCT00894725	Colon Cancer Benign Disease	laparoscopic le... open left colon...	18 Years -	Università Vita-Salute San Raffaele
Laparoscopic Versus Open Left Colonic Resection	NCT00894725	Colon Cancer Benign Disease	laparoscopic le... open left colon...	18 Years -	Università Vita-Salute San Raffaele
Analyzing the Composition of Tears to Identify Cancer	NCT00574678	Breast Cancer Ovarian Cancer Colon Cancer Benign Disease	Tear collection	18 Years -	University of Arkansas
China CellSearch Study	NCT01116869	Metastatic Brea... Benign Breast D...		18 Years - 70 Years	Johnson & Johnson Medical, China

Spots Global Cancer Trial Database for benign disease