Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Observational study of women with Stage II/III locally advanced breast cancer in Latin America

Thomas G Gross, M.D.

Background:

- Researchers want to learn more about breast cancer in Latin American women. They also want to learn how and why women respond differently to standard treatment. Tissue and blood samples from women with breast cancer are needed to study this disease in order to find new ways to prevent, diagnose, and treat it.

Objective:

- To learn more about the biology and genetics of breast cancer in Latin American women.

Eligibility:

- Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II or III breast cancer. They must still be active and able to self-care.

Design:

* Participants are only agreeing to have extra tissue or blood samples collected. They are also letting tissue left over from surgery be used for research. No procedures outside of standard care will be done.
* Participants may have a medical history, physical exam, and blood tests. They may have a pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have an intravenous needle placed in an arm vein.
* Participants may have a core biopsy. For this, a needle is inserted into the breast. A piece of tissue is extracted.
* Participants who have chemotherapy may have blood taken after treatment/before surgery. Tissue may also be collected.
* Participants will complete a questionnaire. It will ask about their social and economic background. It will ask about their family history of cancer. It will also ask about access to diagnosis and treatment of breast cancer.
* Participants may be followed for up to 5 years.

The primary objective of this study is to characterize the distribution of molecular profiles in Latin American women with AJCC 7 clinical stage II or III breast cancer. The molecular profiles will be correlated with epidemiological, histological, and clinical characteristics, including pathologic response to standard neoadjuvant chemotherapy. Moreover, this study intends to define a molecular signature that will predict response to neoadjuvant therapy in breast cancer. This is a prospective cohort study in which no investigational drugs will be administered to participants. The study will be conducted at participating institutions in Argentina, Brazil, Chile, Mexico, and Uruguay.

Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment

This project will provide valuable information on the effectiveness of standard chemotherapy in Latin American women.

National Cancer Institute (NCI)

Symptoms and General Pathology

Death

Members of the AARP, aged 50-71 years, and who resided in one of six states

Rashmi Sinha, Ph.D.

This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.

In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.

This is a prospective cohort study to investigate relations among diet, lifestyle and cancer. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-96 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument. In 2004-2006 we mailed a follow-up questionnaire to all living participants to assess non-cancer endpoints and lifestyle factors.

A Prospective Study of Diet and Cancer in Members of the American Association of Retired Persons

NCI-AARP Diet and Health Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

A. Richters, PhD

Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands

Prospective Bladder Cancer Infrastructure (ProBCI)

Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)

Individual patient data are available upon request to other research groups (please see www.probci.nl for procedure).

QLQ-C30 (Quality of Life Questionnaire-Cancer)

Prospective Bladder Cancer Infrastructure Foundation

Carcinogenesis

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Multi-omics analysis of 5000 prospectively collected samples.

Observation

Tingbo Liang, PhD

Qi Zhang

This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.

This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.

The fresh blood, urine, feces and saliva of each patient will be collected during the surveillance. The samples of each patient will be collected at the following time points: 1) at diagnosis time of IPMN; 2) every 6 months during surveillance until malignant transformation. If patients receive surgical resection for targeted lesions, surgical specimens will also be collected.

Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas

The Second Hospital of Hebei Medical University

Second Affiliated Hospital of Nanchang University

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Huizhou Municipal Central Hospital

Shengzhou People's Hospital

Zhejiang University

The chairman of the First Affiliated Hospital of Zhejiang

Immunomodulating Agents

Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity.

Urine collection at initiation of immunotherapy.

Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.

ImmuCCo Cohort

Julien THERY

Marjane BELMIMOUN

Alexandra FORESTIER

Alexandra FORESTIER, MD

ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.

The aim of this study is to establish a prospective clinic-biologic database of patients treated by immunotherapy. This database will allowed to carry out works (such as translational research) aiming at assessing immunotherapy in real life situation.

Other objectives of the study include:

* Describe overall survival, progression-free survival, response to immunotherapy (in particular hyper-progression, pseudo-progression) considering the first tumor assessment and the best response, prolonged response
* Identifying prognostic factors of overall survival, progression-free survival, hyper-progression, best response under immunotherapy
* Describe AEs (Adverse Events) potentially associated with immunotherapy, their kinetics of appearance, from the start of treatment and after the end of treatment in order to assess the risk of delayed appearance
* To identify factors associated with increased risk of severe adverse event (grade \> 2 or leading to end of treatment) potentially related to immunotherapy, from the beginning of immunotherapy to 1 year after this start of the treatment, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
* Identifying delayed adverse events potentially related to immunotherapy, occurring between 90 days and 1 year after the treatment discontinuation, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
* To identify and describe rare toxicities
* To evaluate the association between co-medications and disease evolution
* To evaluate the association between co-medications and toxicities occurrence

Translational research objectives:

* To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:

  * Establishment of serum and plasma bank which will be used for diverse works;
  * A systematic analysis of the lymphocyte profile
* To study the impact of tabagism on efficacy and toxicity of immunotherapy from systematic collection of urinary cotinine.

Observational study model with additional blood samples and urine collection

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

Number of patients treated by immunotherapy and registered in the database

Time between date of start of immunotherapy to date of death whatever the cause. Patients alive at last follow-up will be censored.

Time between start of immunotherapy to date of disease progression or death whatever the cause. Alive, non-progressive patients at last follow-up will be censored.

Tumor response will be based on the first tumor assessment performed during the immunotherapy. Objective response according to iRECIST (Response Evaluation Criteria in Solid Tumours for immunotherapy) criteria will be defined at the first tumor assessment and during the course of the treatment, meaning until disease progression of start of another systemic treatment.

Responses will be: Complete response (iCR), partial response (iPR), stability (iSD), progression, or pseudo-progression. Confirmed progressive disease (iCPD) will be distinguished from pseudo-progression (iUPD) according to control images. Hyper-progression will be defined as a progression according to iRECIST criteria and a doubling of tumor growth rate.

A prolonged tumor response will be defined as a progression free survival duration at least 3 time superior to median duration of progression free survival of patients of the study presenting the same disease.

All comedications given during the course of the study will be compiled

All Adverse events occuring from the start of the immunotherapy to the follow-up performed on year after the end of the immunotherapy will be notified, whatever the grade and the relationship with immunotherapy, apart from those undoubtfully related to the disease or the progression of the disease.The AE will also be notified in case of start of a second line of treatment, apart from thos undoubtfully related to this second line of treatment. The main analysis will be done on AE potentially related to immunotherapy. The relationship will be evaluated by a medical expert of immunotherapy. AE will be graded according to CTCAE v5.0 classification. Patients who received less than 4 doses will be considered non-evaluable for this outcome apart from those who discontinued treatment because they had a toxicity. Each AE with a grade \> 2 and/or leading to treatment discontinuation will be considered as severe.

Institut National de la Santé Et de la Recherche Médicale, France

Centre Oscar Lambret

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Metaplasia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Dominique LAMARQUE, MD, PhD

This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.

As secondary objectives, among the patients included in the cohort, the study will:

* assess the incidence of low grade dysplasia,
* assess the incidence of high grade dysplasia in patients with low grade dysplasia,
* identify risk factors of progression to dysplasia and gastric cancer.

This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.

All patients will undergo an endoscopy with gastric sampling in order to biopsy:

* 1 sample each in anterior and posterior surfaces of antrum
* 1 sample in lesser curvature
* 1 sample each in anterior and posterior surfaces of body of stomach

Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.

During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:

* patients with intestinal metaplasia: gastroscopy at 36 months.
* patients with dysplasia: an annual gastroscopy will be performed.

In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:

* 4 circumferential samplings of antrum
* 1 sampling of curvature
* 4 circumferential samplings of body of stomach

Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.

Percentage of development of low grade dysplasia in patients initially with intestinal metaplasia without dysplasia.

Percentage of development in 3 years of gastric cancer or high grade dysplasia lesion, in patients initially with low grade dysplasia.

Société nationale française de gastro-entérologie

Assistance Publique - Hôpitaux de Paris

Neoplasm Metastasis

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Members of AARP, aged 50-71 years and who resided in one of six states or in two metropolitan areas in the United States

Background:

The NIH and the American Association of Retired Persons (AARP) conducted a Diet and Health Study. It studied the links between diet, cancer, and cause of death in a group of middle-aged people in the U.S. Researchers want to learn more about how diet and lifestyle can affect cancer and mortality.

Objective:

To clarify links between diet, lifestyle, cancer, death, and chronic diseases.

Eligibility:

AARP members ages 50 to 71 who took part in study #OH95CN025 and lived in California, Florida, Pennsylvania, New Jersey, North Carolina, Louisiana, Atlanta, or Detroit in 1995 1996.

Design:

This study will use existing data and samples. Participants will not be contacted.

Participants personal data, like name, date of birth, and address, will be used. This data will be kept private. Their data and samples will get a unique ID.

Data from other follow-up studies will be used.

Cancer outcome data will be obtained from the 8 sample areas. Many participants have moved to Arizona, Nevada, and Texas. Data will be obtained from those states as well.

Cause of death and date of death will be obtained from the National Death Index.

Cheek swab samples were gathered from 2004 to 2005. They will be used to study the oral microbiome.

The University of Washington (UW) will be added as a study site. UW will study air pollution.

The process of linking with the Virtual Pooled Registry Cancer Linkage System will be explored. It uses one system. Right now, 11 state systems are used to get and link data.

Paper records will be stored in locked file rooms. Electronic data will be stored on secure servers.

Study Description

The purpose of this study is to analyze the data that have been collected as part of NIH-AARP study (OH95CN025), a historical cohort; in this study we seek to continue to conduct research, but no new study activities will be requested from the study participants.

Objective

To examine relationships between diet, lifestyle, and cancers by means of a prospective cohort design

To examine relationships between diet, lifestyle, and mortality by means of a prospective cohort design

To examine relationships between diet, lifestyle, and chronic diseases

Study Population

Data and samples from 566,398 members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment	NCT02326857	Breast Cancer		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
A Prospective Study of Diet and Cancer in Members of the American Association of Retired Persons	NCT00340015	Death Cancer		50 Years - 71 Years	National Institutes of Health Clinical Center (CC)
Prospective Bladder Cancer Infrastructure (ProBCI)	NCT04503577	Bladder Cancer		18 Years -	Prospective Bladder Cancer Infrastructure Foundation
Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas	NCT05433935	Intraductal Pap...	Observation	0 Years - 90 Years	Zhejiang University
Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy	NCT05223608	Solid Tumor, Ad...	ImmuCCo Cohort	18 Years -	Centre Oscar Lambret
Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia	NCT02325323	Stomach Cancer		18 Years -	Assistance Publique - Hôpitaux de Paris
Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment	NCT02326857	Breast Cancer		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data	NCT04750915	Cancer Mortality Chronic Disease...		50 Years - 71 Years	National Institutes of Health Clinical Center (CC)
Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas	NCT05433935	Intraductal Pap...	Observation	0 Years - 90 Years	Zhejiang University

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