CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0003002: Breast carcinomaHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (11)


Name (Synonyms) Correlation
drug1016 Growth Mindset Wiki 0.50
drug1299 Ketotifen 1 MG Wiki 0.50
drug779 Discontinuation of ACEi/ARB Wiki 0.50
drug948 Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC) Wiki 0.50
drug2066 Remain COVID Free SSI Wiki 0.50
drug951 Flexitouch Plus with Cellular Connectivity (FT-CC) Wiki 0.50
drug631 Contain COVID Anxiety SSI Wiki 0.50
drug632 Continuation of ACEi/ARB Wiki 0.50
drug2895 modification of the planned therapeutic management Wiki 0.50
drug629 Conjunctival swab and nasopharyngeal swab Wiki 0.50
drug636 Control Wiki 0.19

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D001943 Breast Neoplasms NIH 1.00
D002583 Uterine Cervical Neoplasms NIH 0.50
D014594 Uterine Neoplasms NIH 0.50
D014625 Vaginal Neoplasms NIH 0.50
D000072656 Breast Cancer Lymphedema NIH 0.50
D014846 Vulvar Neoplasms NIH 0.50
D008209 Lymphedema NIH 0.50
D010051 Ovarian Neoplasms NIH 0.35
D009369 Neoplasms, NIH 0.11

Correlated HPO Terms (7)


Name (Synonyms) Correlation
HP:0100650 Vaginal neoplasm HPO 0.50
HP:0030416 Vulvar neoplasm HPO 0.50
HP:0030079 Cervix cancer HPO 0.50
HP:0010784 Uterine neoplasm HPO 0.50
HP:0001004 Lymphedema HPO 0.50
HP:0100615 Ovarian neoplasm HPO 0.35
HP:0002664 Neoplasm HPO 0.11

There are 4 clinical trials

Clinical Trials


1 Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

NCT04351139 Gynecologic Cancer Breast Neoplasm Female Uterine Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Other: modification of the planned therapeutic management
MeSH:Breast Neoplasms Ovarian Neoplasms Uterine C Uterine Cervical Neoplasms Uterine Neoplasms Vulvar Neoplasms Vaginal Neoplasms Neoplasms
HPO:Breast carcinoma Cervical polyp Cervix cancer Neoplasm Neoplasm of the breast Ovarian neoplasm Uterine neoplasm Vaginal neoplasm Vulvar neoplasm

Primary Outcomes

Description: modification of the planned therapeutic management

Measure: percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)

Time: Day O

2 An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

This single arm, multicenter study provides the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who are currently receiving pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV). The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 400 participants with HER2+ breast cancer who have completed concurrent chemotherapy with P+H IV and are currently receiving or will be receiving maintenance therapy with pertuzumab and trastuzumab. Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV they received prior to enrolling in this study. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

NCT04395508 HER2-positive Breast Cancer Drug: Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC)
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast


3 A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)

The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.

NCT04432727 Breast Cancer Lymphedema Device: Flexitouch Plus with Cellular Connectivity (FT-CC)
MeSH:Breast Neoplasms Lymphedema Breast Cancer Lymphedema
HPO:Breast carcinoma Lymphedema Neoplasm of the breast

Primary Outcomes

Description: Compare the rate of compliance (defined as the number of days device used/total study days) in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.

Measure: Compliance

Time: Changes between 30 days after device training and 60 days after device training

Secondary Outcomes

Description: Comparison of partially compliant and compliant arm girth in patients treated with FT-CC. Arm girth is measured in cm.

Measure: Change in Arm Girth

Time: Changes between baseline, 30 days after device training, and 60 days after device training

Description: Comparison of partially compliant and compliant quality of life in patients treated with FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM). Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.

Measure: Quality of Life Assessment via LYMQOL ARM

Time: Changes between baseline, 30 days after device training, and 60 days after device training

Description: Comparison of partially compliant and compliant quality of life in patients treated with FT-CC by via The RAND 36-Item Short Form Survey (SF-36). The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.

Measure: Quality of Life Assessment via SF-36

Time: Changes between baseline, 30 days after device training, and 60 days after device training

Description: Comparison of partially compliant and compliant symptoms in patients treated with FT-CC by via The Lymphedema Symptom Intensity and Distress Survey-ARM (LSIDS-A). The Lymphedema Symptom Intensity and Distress Survey is a questionnaire used to assess intensity and distress of symptoms in patients with lymphedema of the arm. This includes sub-scores for soft tissue sensation (range 0-10), neurological sensation (0-10), function, (0-10), biobehavioral (0-10), resource (0-10), sexuality (0-10), activity (0-10). Higher score represents worse outcome.

Measure: Symptoms Assessment via LSIDS-A

Time: Changes between baseline, 30 days after device training, and 60 days after device training

4 Ketotifen: Novel Use as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy as Well as the Potential Beneficial Effects of Ketotifen in the Hypothetical Management of COVID-19

The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).

NCT04435028 Breast Cancer Iron Chelation Drug: Ketotifen 1 MG
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

Primary Outcomes

Description: the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done

Measure: prophylaxis effect of Ketotifen on patient`s hearts during the treatment of anthracyclines

Time: 6 months


HPO Nodes