Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Melanoma

Head and Neck Neoplasms

Thoracic Neoplasms

Genital Neoplasms, Female

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neuroendocrine Tumor

Neuroepithelioma

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer

Participants will be enrolled into either IM@Home or enhanced usual care for the study duration of 12 weeks.

IM@Home is an online mind-body program consisted of a series of virtual, synchronous classes that offer a variety of rigorously tested mind-body therapies led by an Integrative Medicine Service (IMS) clinical therapist. The virtual mind-body group therapy sessions will be conducted using Zoom video conferencing platform.

IM@Home

Patients in the enhanced usual care will receive usual care. In addition, once enrolling into the trial, they will be given a handout to encourage them to visit the MSK's multimedia page on the Integrative Medicine website to access pre-recorded, on-demand meditation videos/audios

Enhanced usual care

Jun Mao, MD, MSCE

Tony Hung, MD

The purpose of this study is to find out whether the Integrative Medicine at Home (IM@Home) program can help reduce patients' symptoms (such as tiredness, pain, or insomnia) and improve their satisfaction with treatment for their disease. The IM@Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice. Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind.

A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Primary outcome will be measured by the average fatigue severity measured by the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument designed to assess one construct of fatigue severity in cancer and non-cancer populations. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes."59 A composite fatigue severity score can be found by averaging the 9 item scores.

Memorial Sloan Kettering Cancer Center

Uterine Cervical Neoplasms

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

GT201 treatment for advanced gynecological tumors (advanced cervical cancer)

Autologous tumor infiltrating lymphocyte injection（GT201）

Zhongping Cheng, PHD

This study is an early exploration clinical study with one arm.

The study consists of two stages, namely the dose escalation stage and the dose extension stage:

Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer)

Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer)

Safety Profile Measured by Grade ≥3 TRAEs by CTCAE 5.0

Grit Biotechnology

All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

For the evaluation of patients affected by endometrial cancer, the correlations between semi-quantitative PET parameters (SUVmax, SUVmean, MTV and TLG calculated at different SUVmax thresholds) and histological data, such as for example myometrial invasion, will be investigated. lymph node invasion, tumor grade and type, risk level, probability of mutation of the p53 gene, etc.

In addition to traditional imaging parameters we will also investigate the usefulness of radiomic features, i.e. quantitative data extracted from PET images (PET/CT or PET/MRI), in predicting and explaining histological data

the diagnostic and prognostic value of PET/MRI and PET/CT with 18F-FDG in patients presenting with gynecological tumors

Arturo Chiti

Alessandra Maielli

Gynecological cancers involve several tumors of the female reproductive system. The five most common gynecological tumors are those of the uterine cervix, endometrium, ovary, vagina and vulva. Furthermore, although rarer, there is a further gynecological tumor, which is generated from the gestational trophoblast tissue.These pathologies represent an important burden for society since there are over nine hundred thousand cases in Europe.

Ultrasound examination is the investigation commonly used to monitor high-risk women.

Magnetic resonance imaging (MRI) is considered the most accurate imaging technique for presurgical staging of gynecological tumors. Computed tomography (CT), on the other hand, is not usually used for diagnosis, but is considered very useful for investigating possible distant metastases.Finally, integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting, including gynecological malignancies.

The present study is of considerable clinical relevance as at our Institute it is possible to have a significant number of patients suffering from gynecological neoplastic pathologies that are studied using PET, thus allowing the identification and validation of innovative imaging biomarkers, with the use of both traditional imaging parameters and radiomic features.

Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.

Integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques are able to provide information in predicting and explaining histological data in gynecological tumors.

IRCCS San Raffaele

Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer	NCT05053230	Head and Neck C... Head and Neck T... Thoracic Tumor Thoracic Cancer Gynecologic Can... Gynecologic Tum... Melanoma	IM@Home Enhanced usual ...	18 Years -	Memorial Sloan Kettering Cancer Center
Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer)	NCT06191900	Adult Gynecological T...	Autologous tumo...	18 Years - 70 Years	Grit Biotechnology
Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.	NCT06159907	Gynecological T...	the diagnostic ...	18 Years -	IRCCS San Raffaele

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