Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Stool Collection

Edgar Ben-Josef, MD

A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.

Gut Microbiota And Radiotherapy

Abramson Cancer Center at Penn Medicine

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

People with locally advanced rectal cancer who are to receive induction chemotherapy with FLOFIRINOX followed or not by neo-adjuvant radio-chemotherapy of the Cap50 type.

Stool collection is done with the "Coll-off" device (Zymo research, reference R1101-2-5) provided to the patient before and after the induction treatment and after the reference chemo-radiotherapy treatment (Cap50, Capecitabine). Collection must be carried out by the patient at home (collection using the "Coll-off" device and then transfer to a coproculture jar provided). The fresh sample is then picked up the same day by an approved transporter mandated by the promoter and will be stored at -20°C until the start of the analyses

Stool collection

Marie Vanseymortier

Mehrdad JAFARI

Mathias CHAMAILLARD

This is an observational, single-centre study (RIPH3) for patients with rectal cancer soon to be treated with chemotherapy (+/- neo-adjuvant radio-chemotherapy) looking at the relationship between the composition of the gut microbiota before treatment and the tumour response after chemotherapy +/- radio-chemotherapy

Main objective: The main objective is to test the association between :

* the gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) on the one hand, and
* complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery.

Primary endpoint: The primary endpoint will be complete histological response assessed on the surgical specimen after the neoadjuvant therapy regimen. This assessment will be performed according to the usual standards and blinded to any information on the gut microbiota and on the content of short-chain fatty acids and tryptophan derivatives.

Secondary objectives:

* To explore the profile of gut microbiota composition and short-chain fatty acid content in the two groups of patients (complete histological response or not), assessed before any treatment (T0).
* To assess the changes in the composition of the intestinal flora and the content of short chain fatty acids following treatment with induction chemotherapy (T1), then preoperative radiochemotherapy (T2) if applicable, by comparison of the preoperative sample with the initial sample (T0).
* Assess the association between these taxonomic and metabolic changes (T1-T0, T2-T0) on the one hand and the histological response on the other.
* To evaluate the association between the profile of the composition of the intestinal microbiota and the content of short-chain fatty acids, as well as calprotectin (a reliable and sensitive non-invasive marker of intestinal inflammation) assessed before any treatment (T0) on the one hand, and the occurrence of toxicity during treatment, in particular digestive toxicity.

Secondary endpoints:

* Percentage of different bacteria or families of bacteria (abundance) such as Ruminococcaceae in the intestinal flora and dosage of short-chain fatty acids;
* Rarefaction curves;
* Taxonomic indicators;
* Alpha and beta diversity indices of microbiota composition;
* Determination of calprotectin by ELISA on stool sample.
* Toxicity assessed by collecting adverse events during treatment with FOLFIRINOX and for some patients during radiochemotherapy, graded according to the NCI CTCAE v5 scale and classified according to the MEDDRA dictionary;

Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer

Association Between the Composition of the Intestinal Microbiota Before Treatment and the Tumor Response After Induction Chemotherapy Followed or Not by Neo-adjuvant Radio-chemotherapy in Locally Advanced Rectal Cancer

gut microbiota assessed from a stool sample before the start of neoadjuvant treatment of patients (T0) Measurement of gut microbiota composition at T0 by high-throughput sequencing of the 16S subunit of bacterial ribosomes

complete histological response assessed on the surgical resection specimen in patients with histologically proven stage II and III rectal tumours treated with neo-adjuvant chemotherapy followed or not by Cap50 radiochemotherapy before surgery and according to Ryan classification.

TRG (TRG0-TRG3) TRG 3: extensive residual cancer with no evident tumor regression (poor or not response

INSERM 1003-1

L'Institut des sciences moléculaires (iSm2 UMR CNRS 7313)

Centre Oscar Lambret

Colonic Diseases

In Cohort A: 200 patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) OR with gross bleeding

In cohort B: 200 patients who have already performed colonoscopy candidates for surgery on their colorectal tumor

In cohort A: Blood sample n°1 (PBMC, plasma, ctDNA) previous colonoscopy. If no cancer lesions: STOP. If cancer lesion detected : Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery.

In cohort B: Blood sample n°1 (PBMC, plasma, ctDNA) collected before surgery. Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery

Blood sample

In each cohort, tumor tissue will be collected from the surgical specimen.

Tumor tissue

In cohort B: Stool sample n°1 collected before surgery. Stool sample n°2 collected 1 month after surgery

stool collection

Christophe BORG, Pr

Colorectal cancer (CRC) is the third most common cancer in men and the second in women with an incidence of 43,350 new cases in 2018. This incidence is increasing every year.

Early detection is crucial in this pathology. In France, free screening is organized by health insurance for people aged 50 to 74 years. This screening is based on an immunological test (FIT: Fecal Immunological test), which aims to detect the presence of blood in the stool. In fact, some polyps or cancers cause bleeding that is often minimal and therefore difficult or even impossible to detect with the naked eye.

If this test is positive, a colonoscopy is done to check whether or not abnormalities are present in the colon or rectum. Performed under anesthesia, this examination can detect the possible presence of polyps or cancer.

Recently, with the covid-19 epidemic, the investigators were faced with an extension of the delays for colonoscopies which led to delays in patient care.

To prevent this, they propose to develop a blood test that would allow rapid identification of patients with colorectal cancer, requiring rapid management.

This blood test will permit to have a parameter for stratifying the therapeutic care in the event of epidemia or situation that constrains the organisation of the health system.

Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening

Centre Hospitalier Universitaire de Besancon

The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently inserted less than one inch into the anterior nare (nostril) until resistance is met at turbinate. Then it is rotated several times against nasal wall and repeated in other nostril using the same swab.

Nasal Swab

The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently rubbed along the inside of the participant's cheek for 5-10 seconds.

Oral Swab

A stool collection kit will be sent home with each participant. It will include instructions on how to collect the stool specimen and how to return the kit.

Study of microbial communities found in and on the human body.

Microbiome analysis

Secure, long term storage of an individual's genetic material.

DNA Banking

Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.

Skin Swab

Taher Abu Hejleh, MBBS

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during their regular clinic visits, at the baseline before desired therapy is given, and at the time when treatment is changed due to either disease progression or unbearable toxicities leading to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples will be collected when toxicities reduce to less than grade 1. The samples will be subjected to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The data will be correlated to clinical response from treatments, toxicities, clinical data (use of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for treatment of these subjects.

Bacterial DNA will be isolated from oral, skin, and nasal swabs, as well as stool samples. The extracted DNA will be subsequently used for microbiome analysis.

Microbiome in Lung Cancer and Other Malignancies

The Role of Microbiome in Lung Cancer and Other Malignancies

Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.

Correlate data from samples with patient clinical information regarding overall response rates.

Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy.

Holden Comprehensive Cancer Center

Iowa Institute of Human Genetics

Taher Abu Hejleh

Clinical Associate Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Oculocerebral Syndrome With Hypopigmentation

Premenopausal women between 18-40 years of age.

Diagnosed with PCOS using Rotterdam criteria (meet 2 of the 3):

1. chronic oligo- or amenorrhea (irregular periods during more than a year in combination with a cycle length longer than 35 days);
2. total or free T levels above the reference interval and/or excessive facial hair, acne;
3. transvaginal ultrasound with polycystic ovaries.

Exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency).

Blood sample will be drawn from participants at study entry.

Blood Draw

Stool will be collected from participants at study entry.

Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the investigators will compare the intestinal microbiota composition and diversity in PCOS with age, BMI-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.

The goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. The investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of PCOS. Based on this hypothesis, the investigators propose the following aims:

Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of intestinal microbiota on the development of PCOS.

1. Enroll participants at Drum Tower Hospital. Identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis.
2. Characterize the intestinal microbiota through quantitative PCR and high throughput sequencing analysis of stool specimens in participants.

Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gut Microbiota And Radiotherapy	NCT02559349	Lung Tumor	Stool Collectio...	18 Years -	Abramson Cancer Center at Penn Medicine
Gut Microbiota And Radiotherapy	NCT02559349	Lung Tumor	Stool Collectio...	18 Years -	Abramson Cancer Center at Penn Medicine
Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer	NCT06181201	Cancer of Rectu...	Stool collectio...	18 Years -	Centre Oscar Lambret
Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening	NCT04767568	Colorectal Canc...	Blood sample Tumor tissue stool collectio...	18 Years -	Centre Hospitalier Universitaire de Besancon
Microbiome in Lung Cancer and Other Malignancies	NCT03688347	Lung Cancer Cancer Malignancy	Nasal Swab Oral Swab Stool Collectio... Microbiome anal... DNA Banking Skin Swab	18 Years - 100 Years	University of Iowa
Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer	NCT06181201	Cancer of Rectu...	Stool collectio...	18 Years -	Centre Oscar Lambret
Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer	NCT06181201	Cancer of Rectu...	Stool collectio...	18 Years -	Centre Oscar Lambret
Intestinal Microbiota Survey of Polycystic Ovary Syndrome	NCT02937090	Polycystic Ovar...	Blood Draw Stool collectio...	18 Years - 40 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spots Global Cancer Trial Database for stool collection