araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Spanish Registry of Mohs Surgery

Summary: REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence.
  REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.


Eligibility: Inclusion Criteria:
  -  All consecutive patients considered for Mohs surgery
  Exclusion Criteria:
  -  Under 18 years-old
  -  Legally incompetent

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Summary: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)

Detailed description: The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.

Eligibility: Inclusion Criteria:
  1. Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose.
  2. Patients must be > 15 years of age and must have metastatic melanoma.
  3. Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery.
  4. Patients must be able to understand and sign the Informed Consent document.
  5. Patients must be able to complete the supplemental data form
  Exclusion Criteria:
  1. women who are pregnant or breastfeeding
  2. inability to give consent

Relevance to patient case: definitely relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Inducing Systemic Immunity and Regressions in Metastatic Melanoma

Summary: In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.

Detailed description: Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.

Eligibility: Inclusion Criteria:
  -  Multiple cutaneous or subcutaneous metastases of melanoma
  Exclusion Criteria:
  -  Visceral metastases on admission.
  -  No current chemotherapy or immunotherapy.
  -  Note study performed between 1978 and 2002 before current therapies were available.

Relevance to patient case: definitely relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: 5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results

Summary: The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of medical records from clinical visits with physician.
  The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  -  Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  -  16 Years and older
  Exclusion Criteria:
  -  Less than 16 Years of age

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

Summary: The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.
  The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  -  Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  -  16 Years and older
  Exclusion Criteria:
  -  Less than 16 Years of age

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Peginterferon and TIL Therapy for Metastatic Melanoma

Summary: Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from the patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 are administered to support T cell activation and proliferation in vivo.
  In this trial the therapy is combined with peginterferon (the pegylated form of interferon alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA expression on melanoma cells and are hypothesized to synergize with TIL therapy.


Eligibility: Inclusion Criteria:
  Histologically confirmed unresectable stage III or stage IV metastatic melanoma Metastasis available for surgical resection (about 2 cm3) and residual measurable disease after resection
  ECOG performance status 0-1
  Life expectancy ≥ 3 months
  No significant toxicity from prior treatments
  Adequate renal, hepatic and hematologic function
  Women of childbearing potential (WOCBP) and men in a sexual relationship with a WOCBP must be using an effective method of contraception during treatment and for at least 6 months after completion af treatment.
  Able to comprehend the information given and willing to sign informed consent
  Exclusion Criteria:
  Other Malignancies, unless followed for ≥ 5 years with no sign of disease, except squamous cell carcinoma or adequately treated carcinoma in situ colli uteri.
  Cerebral metastasis. Patients with previously treated CNS metastases can participate if CNS metastases are surgically removed or treated with stereotactic radiosurgery and stable ≥ 28 days after treatment measured by MRI. Patients with asymptomatic, stable and untreated CNS metastasis can in be included according to investigators and sponsors decision.
  Patients with ocular melanoma
  Severe allergies, history of anaphylaxis or known allergies to the administered drugs.
  Serious medical or psychiatric comorbidity
  Creatinine clearance < 70 ml/min
  Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis
  Severe and active autoimmune disease
  Pregnant and nursing women
  Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate
  Concomitant treatment with other experimental drugs
  Patients with uncontrolled hypercalcemia
  Less than four weeks since prior systemic antineoplastic treatment at the time of treatment.

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma

Summary: The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.

Detailed description: The successful treatment of melanoma with immune checkpoint inhibitors, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein 1 (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors. Despite these advances, only a portion of patients experience a durable response suggesting that there is room for improvement via enhanced immunomodulatory approaches. Anti-CTLA-4 (Ipilimumab) significantly improves overall survival and achieves long-lasting complete responses in some melanoma patients, the number of patients that achieve durable clinical benefit is limited and could be improved by a combined immunomodulatory approach. The objectives of this study are to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.

Eligibility: Inclusion Criteria:
  -  Patients over the age of 18 year.
  -  Patients diagnosed with Stage IV melanoma.
  -  Patients that are considered candidates for ipilimumab therapy.
  -  Patients able to understand and willing to sign a written informed consent documents.
  -  Patients willing to have regular blood draws, one before treatment and four during or after treatment.
  Exclusion Criteria:
  -  Patients that have received systemic treatments within four weeks prior to the beginning of treatment.
  -  Women that are pregnant or nursing.
  -  Patients with ocular melanoma.
  -  Patients taking immunosuppressive medications.
  -  Patients with active autoimmune disease.
  -  Patients with known sensitivity to retinoic acid derivatives.

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Melanoma Perception and Health Literacy in People of Color

Summary: This study will examine the effectiveness of a targeted, health literate educational intervention for people of color compared to a standard melanoma education pamphlet for increasing knowledge and promoting early melanoma detection. It is hypothesized that people of color are less aware of their risk for developing melanoma and that a targeted educational intervention will help increase knowledge and promote early melanoma detection especially in individuals with low health literacy.

Detailed description: This targeted educational intervention will compare a standard melanoma education pamphlet with one that has been modified to target people of color. Both pamphlets will include the ABCDEs of melanoma, risk factors, prevention and treatment. In addition, the targeted pamphlet will incorporate the recommendations made by people of color in previous studies. The pamphlets will be randomized to subjects at a study visit along with a health literacy test and a questionnaire aimed at determining subjects' baseline melanoma knowledge and current melanoma prevention practices. 2 months post-intervention, a follow-up phone call will be made to assess subject knowledge retention and behavior change.

Eligibility: Inclusion Criteria:
  -  English-speaking
  -  Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic
  Exclusion Criteria:
  -  Not proficient in English
  -  Unable to give informed consent
  -  Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Hepatic RFA Increases T Cell Infiltraion and PD-L1 Expression in Primary Colorecatl Cancer

Summary: It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human carcinoma. However, there are insufficient studies on the immune modulation of tumor microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in human cancer patients, investigators performed a retrospective study of a unique cohort of patients who suffered from synchronous CRCLM.

Detailed description: Radiofrequency ablation (RFA) is widely used as a local treatment for tumors such as small hepatocellular carcinomas, renal cancer and solitary colorectal cancer liver metastases (CRCLM). RFA induces localized coagulation necrosis and leads to the release of large amounts of cellular debris in situ, which can serve as a source of tumor antigens to elicit host adaptive immune responses against tumors. Several studies on preclinical animal models have shown that localized tumor ablation by RFA can induce systemic T-cell mediated antitumor immunity. Antigen-specific T cell immune responses were also observed in patients with hepatic tumors after RFA therapy. However, the RFA-induced immune responses are not sufficient to prevent tumor recurrence. The underlying mechanisms remain obscure.
  Programmed death-ligand 1 (PD-L1), an important immune checkpoint molecule, is often up-regulated on tumor cells and tumor associated myeloid cells. It impairs T cell-mediated immune responses upon engagement with its cognate co-inhibitory receptor PD-1, which is always highly expressed on tumor-infiltrating lymphocytes. PD-L1 expression can be induced by pro-inflammatory cytokines, especially type I interferon (IFN), as an important self-limiting mechanism to prevent rampant autoimmunity. Recent studies show that PD-L1 expression on tumor cells is associated with T cell infiltration, suggesting PD-L1 is actively involved in suppressing antitumor immune responses in the tumor microenvironment (TME). Whether the PD-L1/PD1 axis is involved in modulating the antitumor T cell immune responses induced by RFA is unclear.
  The objective of this investigation was to study the RFA-induced immune responses in tumor tissues from cancer patients.

Eligibility: Inclusion Criteria:
  Patients with histologically confirmed asynchronous liver metastases received initial hepatic RFA or initial primary tumor resection.
  Exclusion Criteria:
  1. Preoperative CT, RT and other antitumor treatment
  2. Emergency surgery
  3. Initial hepatectomy
  4. No qualified endoscopic biopsy

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Study of DPX-Survivac Vaccine Therapy and Epacadostat in Patients With Recurrent Ovarian Cancer

Summary: Immunotherapeutic survivin vaccine DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents.


Eligibility: Key Inclusion Criteria:
  -  Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
  -  Platinum-resistant or -sensitive after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel)
  -  Complete or partial response or stable disease by radiological imaging to most recent standard of care chemotherapy treatment
  -  Evidence of progressive disease with rising CA-125 and/or radiologic progression
  -  Must have measurable disease, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
  -  Ambulatory with an ECOG 0-1
  -  Life expectancy ≥ 6 months
  -  Meet protocol-specified lab requirements
  Key Exclusion Criteria:
  -  Eligible for otherwise curative treatment or undergoing concurrent therapy
  -  Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g. anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T cell co-stimulation) or an IDO inhibitor
  -  Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
  -  Clinical ascites or metastatic pleural fluid
  -  Malignant bowel obstruction
  -  History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
  -  Recent history of thyroiditis
  -  Presence of a serious acute infection or chronic infection
  -  Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
  -  GI condition that might limit absorption of oral agents
  -  Other serious intercurrent chronic or acute illness
  -  Ongoing treatment with steroid therapy or other immunosuppressive
  -  Receipt of monoamine oxidase inhibitors (MAOIs) or UGT1A9 inhibitors
  -  Acute or chronic skin and/or microvascular disorders
  -  Edema or lymphedema in the lower limbs > grade 1

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Yervoy Pregnancy Surveillance Study

Summary: The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age


Eligibility: Inclusion Criteria:
  -  Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
  Exclusion Criteria:
  -  Women whose ipilimumab exposure is outside the window of pregnancy exposure
  -  Pregnancies for which there is only paternal exposure to Yervoy
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Summary: Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation


Eligibility: Inclusion Criteria:
  -  Tumor of 7 mm of thickness or more
  -  Patients treated by proton beam therapy
  -  Patients aged at least 18 years
  -  Patients clearly informed of the study, having received the letter of information and signed the consent
  Exclusion Criteria:
  -  Massive extrascleral extension posterior to the equator
  -  Patients with metastasis at diagnosis.
  -  Patients with glaucoma before the radiation therapy
  -  Patients with opaque media preventing transpupillary thermotherapy
  -  Patients for whom follow up will be difficult due to geographical, social or psychological reasons

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

Summary: Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma

Detailed description: This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.
  The patient will have a blood sample at the following times :
  -  T0: before treatment of the primary tumor.
  -  T1: 1 months after the end of the local treatment.
  -  T2: at 7 months.
  -  Tn: every 6 months up to 3 years.

Eligibility: Inclusion Criteria:
  -  Aged 18 years old or more.
  -  Patient with a recent choroidal melanoma before the start of the specific treatment.
  -  Patient able to stand a blood collection.
  -  Work-up for extension (CT).
  -  Patient explanation given and consent information signed or by legal representative
  Exclusion Criteria:
  -  Patient without social protection / insurance.
  -  Person deprived of liberty or under guardianship.
  -  Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Study of Polyfunctionality of Anti-tumor T Lymphocytes in Cancerology: Potential Biomarker for Emerging Immunotherapies

Summary: Purposes of this study are :
  -  Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro inhibition of PD-1/PDL-1 pathway
  -  Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of patients with melanoma, lung cancer and renal carcinoma. This cancers are chosen because of use of anti-PD-1 or anti-PDL-1 antibodies
  -  Comparison of this technique with IFN-γ Elispot assay for detection and quantification of anti-tumor T lymphocytes after in vitro blockade of PD-1/PDL-1 pathway.

Detailed description: In this study an immunomonitoring of specific responses of T lymphocytes to tumor-associated antigens based on detection of intracellular cytokines through flow cytometry, after stimulation with all-tumor antigens and blockade of PD-1/PDL-1 interaction is used. Peripheral blood mononuclear cells of patients with cancers are stimulated with 4 telomerase-peptides or peptides overlapping the entire sequence of survivin.
  This project studies the frequency and role of polyfunctionality of anti-tumor T lymphocytes in cancerology with an in vitro technique detecting polyfunctional T lymphocytes with a better sensitivity based on removal of an inhibitory PD-1/PDL-1 pathway. It is a flow cytometry protocol with various theoretical advantages in terms of reproducibility and dynamic monitoring of functionality of different sub-populations of polyfunctional anti-tumor T lymphocytes. Moreover, it allows the study of molecular mechanisms involved in proliferation of polyfunctional anti-tumor T lymphocytes with the possibility to sort sub-populations.
  The use of all-tumor antigens allows the use of this technique to evaluate the presence and prognostic or predictive value of this biomarker in various cancers.
  Detection of polyfunctional anti-tumor T lymphocytes can be a biomarker of anti-tumor lymphocytic adaptive immunity and a potential eligibility or efficacy criteria for new immunotherapies, such as anti-PD-1 or anti-PDL-1 treatments.

Eligibility: Inclusion Criteria:
  -  Patients affected by melanoma (LyteloMel), lung cancer (TeloCap) or renal carcinoma (EMIR) from cohorts of medical oncology department of CHRU Besançon (France)
  Exclusion Criteria:

Relevance to patient case: not relevant